Trial Outcomes & Findings for Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism (NCT NCT01965288)

Results Overview

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2020-07-30

Participant Flow

Of the 60 subjects enrolled, 60 were fitted with the study lenses and completed the trial (i.e. no discontinuations).This study design considered a single-center, (Optometry Research Group), located at the University of Valencia Spain (target 60 subjects).

All subjects were habitual lens wearers.

Participant milestones

Participant milestones
Measure	Comfilcon A Then Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B Then Comfilcon A All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comfilcon A Then Lotrafilcon B n=30 Participants All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B Then Comfilcon A n=30 Participants All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Spain	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Daily and Comfortable Wearing Time Average comfortable wearing time	8.8 hours Standard Deviation 2.5	—	—
Daily and Comfortable Wearing Time Average daily wearing time	9.2 hours Standard Deviation 2.6	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort prior to Removal	7.7 units on a scale Standard Deviation 1.6	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort Overall	8.0 units on a scale Standard Deviation 1.6	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort on Insertion	8.0 units on a scale Standard Deviation 1.3	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness during the Day	8.0 units on a scale Standard Deviation 1.6	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness prior to Removal	7.9 units on a scale Standard Deviation 1.6	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness Overall	7.9 units on a scale Standard Deviation 1.6	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Handling	8.4 units on a scale Standard Deviation 1.1	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Overall Lens Fit	8.2 units on a scale Standard Deviation 1.1	—	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Overall Vision Satisfaction	8.1 units on a scale Standard Deviation 1.2	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Quality Insertion, During Day, End Day On Insertion	78.5 units on a scale Standard Deviation 12.4	—	—
Vision Quality Insertion, During Day, End Day During the Day	82.7 units on a scale Standard Deviation 13.2	—	—
Vision Quality Insertion, During Day, End Day End of Day	80.2 units on a scale Standard Deviation 14.3	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Stability Insertion, During Day, End Day On Insertion	78.5 units on a scale Standard Deviation 12.0	—	—
Vision Stability Insertion, During Day, End Day During the Day	83.8 units on a scale Standard Deviation 13.4	—	—
Vision Stability Insertion, During Day, End Day End of Day	82.9 units on a scale Standard Deviation 13.3	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Moistness Excellent	23 percentage of subjects	—	—
Overall Sensation of Moistness Good	25 percentage of subjects	—	—
Overall Sensation of Moistness Average	50 percentage of subjects	—	—
Overall Sensation of Moistness Below Average	0 percentage of subjects	—	—
Overall Sensation of Moistness Poor	2 percentage of subjects	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Smoothness Excellent	27 percentage of participants	—	—
Overall Sensation of Smoothness Good	33 percentage of participants	—	—
Overall Sensation of Smoothness Average	40 percentage of participants	—	—
Overall Sensation of Smoothness Below Average	0 percentage of participants	—	—
Overall Sensation of Smoothness Poor	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort Satisfaction Completely Satisfied	37 percentage of participants	—	—
Comfort Satisfaction Somewhat Satisfied	55 percentage of participants	—	—
Comfort Satisfaction Somewhat Dissatisfied	7 percentage of participants	—	—
Comfort Satisfaction Completely Dissatisfied	2 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Dryness Satisfaction Completely Satisfied	33 percentage of participants	—	—
Dryness Satisfaction Somewhat Satisfied	53 percentage of participants	—	—
Dryness Satisfaction Somewhat Dissatisfied	12 percentage of participants	—	—
Dryness Satisfaction Completely Dissatisfied	2 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Handling Satisfaction Completely Satisfied	57 percentage of participants	—	—
Handling Satisfaction Somewhat Satisfied	37 percentage of participants	—	—
Handling Satisfaction Somewhat Dissatisfied	5 percentage of participants	—	—
Handling Satisfaction Completely Dissatisfied	2 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Fit Satisfaction Completely Satisfied	42 percentage of participants	—	—
Lens Fit Satisfaction Somewhat Satisfied	50 percentage of participants	—	—
Lens Fit Satisfaction Somewhat Dissatisfied	8 percentage of participants	—	—
Lens Fit Satisfaction Completely Dissatisfied	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Satisfaction Completely Satisfied	48 percentage of participants	—	—
Vision Satisfaction Somewhat Satisfied	45 percentage of participants	—	—
Vision Satisfaction Somewhat Dissatisfied	7 percentage of participants	—	—
Vision Satisfaction Completely Dissatisfied	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Satisfaction Completely Satisfied	40 percentage of participants	—	—
Overall Satisfaction Somewhat Satisfied	53 percentage of participants	—	—
Overall Satisfaction Somewhat Dissatisfied	7 percentage of participants	—	—
Overall Satisfaction Completely Dissatisfied	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort Upon Contact Lens Insertion	9.0 units on a scale Standard Deviation 0.8	7.8 units on a scale Standard Deviation 1.2	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Satisfaction Upon Contact Lens Insertion	8.8 units on a scale Standard Deviation 1.1	8.2 units on a scale Standard Deviation 1.3	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Quality With Contact Lens Prescription	88 units on a scale Standard Deviation 9.3	82 units on a scale Standard Deviation 11.9	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Stability Upon Contact Lens Insertion	87 units on a scale Standard Deviation 11.9	82 units on a scale Standard Deviation 11.7	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Visual Acuity logMAR MHCVA (OU Average)	-0.02 logMAR Standard Deviation 0.05	-0.01 logMAR Standard Deviation 0.06	—
Visual Acuity logMAR MLCVA (OU Average)	0.18 logMAR Standard Deviation 0.05	0.19 logMAR Standard Deviation 0.07	—
Visual Acuity logMAR BHCVA	-0.04 logMAR Standard Deviation 0.06	-0.02 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR BLCVA	0.17 logMAR Standard Deviation 0.07	0.18 logMAR Standard Deviation 0.05	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Centration centered	94 percentage of lenses	79 percentage of lenses	—
Centration slightly decentered	6 percentage of lenses	21 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Coverage	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Post Blink Movement	0.09 units on a scale Standard Deviation 0.30	0.19 units on a scale Standard Deviation 0.42	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Orientation Primary Gaze	0.71 degrees Standard Deviation 1.75	1.06 degrees Standard Deviation 1.90	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Marking Visibility Excellent	89 percentage of lenses	42 percentage of lenses	—
Lens Marking Visibility Average	11 percentage of lenses	42 percentage of lenses	—
Lens Marking Visibility Poor	0 percentage of lenses	16 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability on Blink No rotation	100 percentage of lenses	98 percentage of lenses	—
Lens Stability on Blink 5-10 degrees	0 percentage of lenses	2 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability 5-10 Min	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Overall Stability Excellent	80 percentage of lenses	50 percentage of lenses	—
Lens Overall Stability Good	20 percentage of lenses	50 percentage of lenses	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Rotational Recovery 30/45 Deg 30 deg/ 10 blinks	0.542 degrees Standard Deviation 1.56	0.833 degrees Standard Deviation 1.98	—
Rotational Recovery 30/45 Deg 45 deg/ 60 sec	0.625 degrees Standard Deviation 1.66	0.875 degrees Standard Deviation 2.01	—

PRIMARY outcome

Timeframe: Dispense

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Fit Acceptance Perfect	82 percentage of lenses fitted	57 percentage of lenses fitted	—
Overall Fit Acceptance Not Perfect	18 percentage of lenses fitted	43 percentage of lenses fitted	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Daily and Comfortable Wearing Time average comfortable wearing time	9.8 hours Standard Deviation 2.3	8.3 hours Standard Deviation 3.0	—
Daily and Comfortable Wearing Time average daily wearing time	10.1 hours Standard Deviation 2.0	10.1 hours Standard Deviation 1.8	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Daily and Comfortable Wearing Time average comfortable wearing time	9.5 hours Standard Deviation 2.1	7.8 hours Standard Deviation 2.8	—
Daily and Comfortable Wearing Time average daily wearing time	9.9 hours Standard Deviation 1.7	9.8 hours Standard Deviation 1.7	—

PRIMARY outcome

Timeframe: 2 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participants Use of Rewetting Drops	7 percentage of participants	50 percentage of participants	—

PRIMARY outcome

Timeframe: 4 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participants Use of Rewetting Drops	15 percentage of participants	58 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort on Insertion	8.7 units on a scale Standard Deviation 1.1	7.7 units on a scale Standard Deviation 1.3	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort prior to Removal	8.7 units on a scale Standard Deviation 1.1	7.4 units on a scale Standard Deviation 1.4	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort Overall	8.8 units on a scale Standard Deviation 1.1	7.6 units on a scale Standard Deviation 1.3	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness during the Day	8.7 units on a scale Standard Deviation 1.3	7.6 units on a scale Standard Deviation 1.4	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness prior to Removal	8.6 units on a scale Standard Deviation 1.5	7.5 units on a scale Standard Deviation 1.5	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness Overall	8.7 units on a scale Standard Deviation 1.3	7.5 units on a scale Standard Deviation 1.5	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Handling	8.3 units on a scale Standard Deviation 1.1	8.0 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Lens Fit Stability	8.8 units on a scale Standard Deviation 1.2	8.0 units on a scale Standard Deviation 1.5	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Vision Satisfaction	8.7 units on a scale Standard Deviation 1.1	8.0 units on a scale Standard Deviation 1.5	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort on Insertion	8.6 units on a scale Standard Deviation 1.0	7.1 units on a scale Standard Deviation 1.5	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort prior to Removal	8.5 units on a scale Standard Deviation 1.1	6.7 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Comfort Overall	8.6 units on a scale Standard Deviation 1.1	6.9 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness during the Day	8.5 units on a scale Standard Deviation 1.1	7.0 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness prior to Removal	8.5 units on a scale Standard Deviation 1.1	7.0 units on a scale Standard Deviation 1.5	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Dryness Overall	8.6 units on a scale Standard Deviation 1.1	7.0 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Handling	8.2 units on a scale Standard Deviation 1.1	7.8 units on a scale Standard Deviation 1.7	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Lens Fit Stability	8.6 units on a scale Standard Deviation 1.1	7.6 units on a scale Standard Deviation 1.6	—
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Vision Satisfaction	8.5 units on a scale Standard Deviation 1.0	7.6 units on a scale Standard Deviation 1.6	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Quality Insertion, During Day, End Day, Night Night	84 units on a scale Standard Deviation 9	80 units on a scale Standard Deviation 12	—
Vision Quality Insertion, During Day, End Day, Night On Insertion	88 units on a scale Standard Deviation 8	84 units on a scale Standard Deviation 9	—
Vision Quality Insertion, During Day, End Day, Night During the Day	89 units on a scale Standard Deviation 9	85 units on a scale Standard Deviation 10	—
Vision Quality Insertion, During Day, End Day, Night End of Day	87 units on a scale Standard Deviation 9	83 units on a scale Standard Deviation 11	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Quality Insertion, During Day, End Day, Night During the Day	88 units on a scale Standard Deviation 10	82 units on a scale Standard Deviation 13	—
Vision Quality Insertion, During Day, End Day, Night On Insertion	85 units on a scale Standard Deviation 10	79 units on a scale Standard Deviation 11	—
Vision Quality Insertion, During Day, End Day, Night End of Day	86 units on a scale Standard Deviation 11	80 units on a scale Standard Deviation 13	—
Vision Quality Insertion, During Day, End Day, Night Night	83 units on a scale Standard Deviation 10	76 units on a scale Standard Deviation 12	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Stability on Insertion, During Day, End Day On Insertion	87 units on a scale Standard Deviation 9	83 units on a scale Standard Deviation 11	—
Vision Stability on Insertion, During Day, End Day During the Day	91 units on a scale Standard Deviation 9	85 units on a scale Standard Deviation 13	—
Vision Stability on Insertion, During Day, End Day End of Day	89 units on a scale Standard Deviation 10	84 units on a scale Standard Deviation 12	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Stability on Insertion, During Day, End Day On Insertion	85 units on a scale Standard Deviation 10	80 units on a scale Standard Deviation 13	—
Vision Stability on Insertion, During Day, End Day During the Day	87 units on a scale Standard Deviation 11	82 units on a scale Standard Deviation 14	—
Vision Stability on Insertion, During Day, End Day End of Day	86 units on a scale Standard Deviation 9	80 units on a scale Standard Deviation 13	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Moistness Excellent	57 percentage of participants	20 percentage of participants	—
Overall Sensation of Moistness Good	30 percentage of participants	30 percentage of participants	—
Overall Sensation of Moistness Average	13 percentage of participants	33 percentage of participants	—
Overall Sensation of Moistness Below Average	0 percentage of participants	12 percentage of participants	—
Overall Sensation of Moistness Poor	0 percentage of participants	5 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Moistness Excellent	60 percentage of participants	18 percentage of participants	—
Overall Sensation of Moistness Good	27 percentage of participants	23 percentage of participants	—
Overall Sensation of Moistness Average	12 percentage of participants	30 percentage of participants	—
Overall Sensation of Moistness Below Average	2 percentage of participants	25 percentage of participants	—
Overall Sensation of Moistness Poor	0 percentage of participants	3 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Smoothness Excellent	48 percentage of participants	27 percentage of participants	—
Overall Sensation of Smoothness Good	38 percentage of participants	30 percentage of participants	—
Overall Sensation of Smoothness Average	13 percentage of participants	30 percentage of participants	—
Overall Sensation of Smoothness Below Average	0 percentage of participants	12 percentage of participants	—
Overall Sensation of Smoothness Poor	0 percentage of participants	2 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Sensation of Smoothness Excellent	47 percentage of participants	13 percentage of participants	—
Overall Sensation of Smoothness Good	42 percentage of participants	38 percentage of participants	—
Overall Sensation of Smoothness Average	10 percentage of participants	28 percentage of participants	—
Overall Sensation of Smoothness Below Average	2 percentage of participants	17 percentage of participants	—
Overall Sensation of Smoothness Poor	0 percentage of participants	3 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort Satisfaction Completely Satisfied	72 percentage of participants	25 percentage of participants	—
Comfort Satisfaction Somewhat Satisfied	23 percentage of participants	45 percentage of participants	—
Comfort Satisfaction Somewhat Dissatisfied	5 percentage of participants	28 percentage of participants	—
Comfort Satisfaction Completely Dissatisfied	0 percentage of participants	2 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Comfort Satisfaction Somewhat Satisfied	23 percentage of participants	37 percentage of participants	—
Comfort Satisfaction Somewhat Dissatisfied	5 percentage of participants	27 percentage of participants	—
Comfort Satisfaction Completely Satisfied	72 percentage of participants	27 percentage of participants	—
Comfort Satisfaction Completely Dissatisfied	0 percentage of participants	10 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Dryness Satisfaction Completely Satisfied	73 percentage of participants	32 percentage of participants	—
Dryness Satisfaction Somewhat Satisfied	27 percentage of participants	42 percentage of participants	—
Dryness Satisfaction Somewhat Dissatisfied	0 percentage of participants	25 percentage of participants	—
Dryness Satisfaction Completely Dissatisfied	0 percentage of participants	1.7 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Dryness Satisfaction Completely Satisfied	77 percentage of participants	23 percentage of participants	—
Dryness Satisfaction Somewhat Satisfied	13 percentage of participants	35 percentage of participants	—
Dryness Satisfaction Somewhat Dissatisfied	10 percentage of participants	32 percentage of participants	—
Dryness Satisfaction Completely Dissatisfied	0 percentage of participants	10 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Handling Satisfaction Completely Satisfied	47 percentage of participants	45 percentage of participants	—
Handling Satisfaction Somewhat Satisfied	42 percentage of participants	43 percentage of participants	—
Handling Satisfaction Somewhat Dissatisfied	12 percentage of participants	10 percentage of participants	—
Handling Satisfaction Completely Dissatisfied	0 percentage of participants	1.7 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Handling Satisfaction Completely Satisfied	42 percentage of participants	40 percentage of participants	—
Handling Satisfaction Somewhat Satisfied	48 percentage of participants	48 percentage of participants	—
Handling Satisfaction Somewhat Dissatisfied	10 percentage of participants	12 percentage of participants	—
Handling Satisfaction Completely Dissatisfied	0 percentage of participants	0 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Satisfaction Completely Satisfied	70 percentage of participants	43 percentage of participants	—
Vision Satisfaction Somewhat Satisfied	30 percentage of participants	48 percentage of participants	—
Vision Satisfaction Somewhat Dissatisfied	0 percentage of participants	7 percentage of participants	—
Vision Satisfaction Completely Dissatisfied	0 percentage of participants	2 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Vision Satisfaction Completely Satisfied	63 percentage of participants	35 percentage of participants	—
Vision Satisfaction Somewhat Satisfied	32 percentage of participants	53 percentage of participants	—
Vision Satisfaction Somewhat Dissatisfied	5 percentage of participants	12 percentage of participants	—
Vision Satisfaction Completely Dissatisfied	0 percentage of participants	0 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Fit Satisfaction Completely Satisfied	70 percentage of participants	45 percentage of participants	—
Lens Fit Satisfaction Somewhat Satisfied	27 percentage of participants	47 percentage of participants	—
Lens Fit Satisfaction Somewhat Dissatisfied	3 percentage of participants	7 percentage of participants	—
Lens Fit Satisfaction Completely Dissatisfied	0 percentage of participants	2 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Fit Satisfaction Completely Satisfied	70 percentage of participants	35 percentage of participants	—
Lens Fit Satisfaction Somewhat Satisfied	25 percentage of participants	55 percentage of participants	—
Lens Fit Satisfaction Somewhat Dissatisfied	5 percentage of participants	10 percentage of participants	—
Lens Fit Satisfaction Completely Dissatisfied	0 percentage of participants	0 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Satisfaction Completely Satisfied	68 percentage of participants	30 percentage of participants	—
Overall Satisfaction Somewhat Satisfied	30 percentage of participants	45 percentage of participants	—
Overall Satisfaction Somewhat Dissatisfied	2 percentage of participants	23 percentage of participants	—
Overall Satisfaction Completely Dissatisfied	0 percentage of participants	2 percentage of participants	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Satisfaction Completely Satisfied	65 percentage of participants	22 percentage of participants	—
Overall Satisfaction Somewhat Satisfied	28 percentage of participants	45 percentage of participants	—
Overall Satisfaction Somewhat Dissatisfied	7 percentage of participants	27 percentage of participants	—
Overall Satisfaction Completely Dissatisfied	0 percentage of participants	7 percentage of participants	—

PRIMARY outcome

Timeframe: 2 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Wavefront Aberrations Root Mean Square (RMS) (3mm) HOA	0.065 microns Standard Deviation 0.061	0.07 microns Standard Deviation 0.066	—
Wavefront Aberrations Root Mean Square (RMS) (3mm) Third Order	0.043 microns Standard Deviation 0.054	0.046 microns Standard Deviation 0.041	—
Wavefront Aberrations Root Mean Square (RMS) (3mm) Fourth Order	0.034 microns Standard Deviation 0.049	0.029 microns Standard Deviation 0.051	—

PRIMARY outcome

Timeframe: 4 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Wavefront Aberrations RMS (3mm) HOA	0.071 microns Standard Deviation 0.052	0.075 microns Standard Deviation 0.063	—
Wavefront Aberrations RMS (3mm) Third Order	0.047 microns Standard Deviation 0.051	0.05 microns Standard Deviation 0.048	—
Wavefront Aberrations RMS (3mm) Fourth Order	0.033 microns Standard Deviation 0.061	0.03 microns Standard Deviation 0.059	—

PRIMARY outcome

Timeframe: 2 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Wavefront Aberrations RMS (5mm) HOA	0.214 microns Standard Deviation 0.052	0.223 microns Standard Deviation 0.063	—
Wavefront Aberrations RMS (5mm) Third Order	0.156 microns Standard Deviation 0.041	0.161 microns Standard Deviation 0.052	—
Wavefront Aberrations RMS (5mm) Fourth Order	0.071 microns Standard Deviation 0.031	0.075 microns Standard Deviation 0.032	—

PRIMARY outcome

Timeframe: 4 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Wavefront Aberrations RMS (5mm) HOA	0.261 microns Standard Deviation 0.065	0.287 microns Standard Deviation 0.075	—
Wavefront Aberrations RMS (5mm) Third Order	0.161 microns Standard Deviation 0.042	0.167 microns Standard Deviation 0.055	—
Wavefront Aberrations RMS (5mm) Fourth Order	0.075 microns Standard Deviation 0.0291	0.081 microns Standard Deviation 0.034	—

PRIMARY outcome

Timeframe: 2 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Visual Acuity logMAR MHCVA (both eyes Average)	-0.01 logMAR Standard Deviation 0.05	-0.01 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR MLCVA (both eyes Average)	0.19 logMAR Standard Deviation 0.05	0.19 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR BHCVA	-0.04 logMAR Standard Deviation 0.05	-0.03 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR BLCVA	0.17 logMAR Standard Deviation 0.05	0.18 logMAR Standard Deviation 0.05	—

PRIMARY outcome

Timeframe: 4 Weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Visual Acuity logMAR MHCVA (both eyes Average)	-0.01 logMAR Standard Deviation 0.05	-0.01 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR MLCVA (both eyes Average)	0.19 logMAR Standard Deviation 0.05	0.19 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR BHCVA	-0.03 logMAR Standard Deviation 0.05	-0.03 logMAR Standard Deviation 0.05	—
Visual Acuity logMAR BLCVA	0.18 logMAR Standard Deviation 0.05	0.18 logMAR Standard Deviation 0.05	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Orientation Primary Gaze	0.67 degrees Standard Deviation 1.71	1.17 degrees Standard Deviation 2.22	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Orientation Primary Gaze	0.87 degrees Standard Deviation 2.01	1.08 degrees Standard Deviation 2.17	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Rotational Recovery 30/45 Deg 30 deg/ 10 blinks	0.25 degrees Standard Deviation 1.09	0.83 degrees Standard Deviation 1.98	—
Rotational Recovery 30/45 Deg 45 deg/ 60 sec	0.58 degrees Standard Deviation 1.61	0.96 degrees Standard Deviation 2.08	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Rotational Recovery 30/45 Deg 30 deg/ 10 blinks	0.33 degrees Standard Deviation 1.25	0.66 degrees Standard Deviation 1.82	—
Rotational Recovery 30/45 Deg 45 deg/ 60 sec	0.45 degrees Standard Deviation 1.45	0.63 degrees Standard Deviation 1.78	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Surface Deposits	0.26 units on a scale Standard Deviation 0.31	0.41 units on a scale Standard Deviation 0.36	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Surface Deposits	0.41 units on a scale Standard Deviation 0.34	0.71 units on a scale Standard Deviation 0.41	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Centration centered	94 percentage of lenses	78 percentage of lenses	—
Centration slightly decentered	6 percentage of lenses	22 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Centration centered	93 percentage of lenses	81 percentage of lenses	—
Centration slightly decentered	7 percentage of lenses	19 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Coverage	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Coverage	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Post Blink Movement	0 units on a scale Standard Deviation 0	0.05 units on a scale Standard Deviation 0.22	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Post Blink Movement	0.01 units on a scale Standard Deviation 0.09	0.05 units on a scale Standard Deviation 0.22	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Marking Visibility Excellent	88 percentage of lenses	27 percentage of lenses	—
Lens Marking Visibility Average	12 percentage of lenses	49 percentage of lenses	—
Lens Marking Visibility Poor	0 percentage of lenses	24 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Marking Visibility Excellent	84 percentage of lenses	20 percentage of lenses	—
Lens Marking Visibility Average	16 percentage of lenses	50 percentage of lenses	—
Lens Marking Visibility Poor	0 percentage of lenses	30 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability on Blink No rotation	98 percentage of lenses	99 percentage of lenses	—
Lens Stability on Blink 5-10 degrees	2 percentage of lenses	1 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability on Blink No rotation	100 percentage of lenses	99 percentage of lenses	—
Lens Stability on Blink 5-10 degrees	0 percentage of lenses	1 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability 5-10 Min	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lens Stability 5-10 Min	100 percentage of lenses	100 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Stability Excellent	74 percentage of lenses	38 percentage of lenses	—
Overall Stability Good	26 percentage of lenses	62 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Stability Excellent	72 percentage of lenses	36 percentage of lenses	—
Overall Stability Good	28 percentage of lenses	64 percentage of lenses	—

PRIMARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Fit Acceptance Perfect	76 percentage of lenses	49 percentage of lenses	—
Overall Fit Acceptance Not Perfect	24 percentage of lenses	51 percentage of lenses	—

PRIMARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Lenses All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Overall Fit Acceptance Perfect	73 percentage of lenses	44 percentage of lenses	—
Overall Fit Acceptance Not Perfect	27 percentage of lenses	56 percentage of lenses	—

SECONDARY outcome

Timeframe: Baseline

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Limbal Hyperaemia Grade 0	97.5 percentage of eyes	—	—
Limbal Hyperaemia Grade 1/2	2.5 percentage of eyes	—	—
Limbal Hyperaemia Grade 1	0.0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Limbal Hyperaemia Grade 0	99 percentage of eyes	100 percentage of eyes	—
Limbal Hyperaemia Grade 1/2	1 percentage of eyes	0 percentage of eyes	—
Limbal Hyperaemia Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Limbal Hyperaemia Grade 0	98 percentage of eyes	98 percentage of eyes	—
Limbal Hyperaemia Grade 1/2	2 percentage of eyes	2 percentage of eyes	—
Limbal Hyperaemia Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Bulbar Hyperaemia Grade 0	98.4 percentage of eyes	—	—
Bulbar Hyperaemia Grade 1/2	1.6 percentage of eyes	—	—
Bulbar Hyperaemia Grade 1	0.0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Bulbar Hyperaemia Grade 0	100 percentage of eyes	95 percentage of eyes	—
Bulbar Hyperaemia Grade 1/2	0 percentage of eyes	5 percentage of eyes	—
Bulbar Hyperaemia Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Bulbar Hyperaemia Grade 0	100 percentage of eyes	94 percentage of eyes	—
Bulbar Hyperaemia Grade 1/2	0 percentage of eyes	6 percentage of eyes	—
Bulbar Hyperaemia Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lower Palpebral Hyperaemia Grade 0	92.5 percentage of eyes	—	—
Lower Palpebral Hyperaemia Grade 1/2	7.5 percentage of eyes	—	—
Lower Palpebral Hyperaemia Grade 1	0.0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lower Palpebral Hyperaemia Grade 0	96 percentage of eyes	82 percentage of eyes	—
Lower Palpebral Hyperaemia Grade 1/2	4 percentage of eyes	18 percentage of eyes	—
Lower Palpebral Hyperaemia Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Lower Palpebral Hyperaemia Grade 0	93 percentage of eyes	78 percentage of eyes	—
Lower Palpebral Hyperaemia Grade 1/2	7 percentage of eyes	20 percentage of eyes	—
Lower Palpebral Hyperaemia Grade 1	0 percentage of eyes	2 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Stromal Haze Grade 0	100 percentage of eyes	—	—
Corneal Stromal Haze Grade 1/2	0.0 percentage of eyes	—	—
Corneal Stromal Haze Grade 1	0.0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Stromal Haze Grade 0	100 percentage of eyes	100 percentage of eyes	—
Corneal Stromal Haze Grade 1/2	0 percentage of eyes	0 percentage of eyes	—
Corneal Stromal Haze Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Stromal Haze Grade 0	100 percentage of eyes	100 percentage of eyes	—
Corneal Stromal Haze Grade 1/2	0 percentage of eyes	0 percentage of eyes	—
Corneal Stromal Haze Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline

Population: All 60 subjects randomized to both sets of lenses.

Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Neovascularization Grade 1/2	3.3 percentage of eyes	—	—
Corneal Neovascularization Grade 1	0.0 percentage of eyes	—	—
Corneal Neovascularization Grade 0	96.7 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Neovascularization Grade 0	100 percentage of eyes	96 percentage of eyes	—
Corneal Neovascularization Grade 1/2	0 percentage of eyes	4 percentage of eyes	—
Corneal Neovascularization Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Neovascularization Grade 0	100 percentage of eyes	97 percentage of eyes	—
Corneal Neovascularization Grade 1/2	0 percentage of eyes	3 percentage of eyes	—
Corneal Neovascularization Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Infiltrates Grade 0	100 percentage of eyes	—	—
Corneal Infiltrates Grade 1/2	0.0 percentage of eyes	—	—
Corneal Infiltrates Grade 1	0.0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Infiltrates Grade 0	100 percentage of eyes	100 percentage of eyes	—
Corneal Infiltrates Grade 1/2	0 percentage of eyes	0 percentage of eyes	—
Corneal Infiltrates Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Outcome measures

Outcome measures
Measure	Comfilcon A n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=120 Eyes All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Corneal Infiltrates Grade 0	100 percentage of eyes	100 percentage of eyes	—
Corneal Infiltrates Grade 1/2	0 percentage of eyes	0 percentage of eyes	—
Corneal Infiltrates Grade 1	0 percentage of eyes	0 percentage of eyes	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.

Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Comfort	55 percentage of patients	45 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Dryness	57 percentage of patients	43 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Handling	55 percentage of patients	45 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Vision	47 percentage of patients	53 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Lens Fit	43 percentage of patients	57 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Overall	53 percentage of patients	47 percentage of patients	—

SECONDARY outcome

Timeframe: 2 weeks

Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.

Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Comfort	20 percentage of patients	80 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Dryness	18 percentage of patients	82 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Handling	55 percentage of patients	45 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Vision	25 percentage of patients	75 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Lens Fit	30 percentage of patients	70 percentage of patients	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Overall	25 percentage of patients	75 percentage of patients	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.

Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Comfort	62 percentage of participants	38 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Dryness	58 percentage of participants	42 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Handling	57 percentage of participants	43 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Vision	45 percentage of participants	55 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Lens Fit	52 percentage of participants	48 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Overall	55 percentage of participants	45 percentage of participants	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.

Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Comfort	20 percentage of participants	80 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Dryness	22 percentage of participants	78 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Handling	52 percentage of participants	48 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Vision	27 percentage of participants	73 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Lens Fit	27 percentage of participants	73 percentage of participants	—
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Overall	23 percentage of participants	77 percentage of participants	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses Very Likely	45 percentage of particpants	10 percentage of particpants	—
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses Likely	32 percentage of particpants	32 percentage of particpants	—
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses Unlikely	22 percentage of particpants	42 percentage of particpants	—
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses Very Unlikely	2 percentage of particpants	17 percentage of particpants	—

SECONDARY outcome

Timeframe: 4 weeks

Population: All 60 subjects randomized to both sets of lenses.

Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participants Likelihood of Continuing to Wear the Study Lenses. Very Likely	45 percentage of participants	12 percentage of participants	—
Participants Likelihood of Continuing to Wear the Study Lenses. Likely	32 percentage of participants	30 percentage of participants	—
Participants Likelihood of Continuing to Wear the Study Lenses. Unlikely	22 percentage of participants	42 percentage of participants	—
Participants Likelihood of Continuing to Wear the Study Lenses. Very Unlikely	2 percentage of participants	17 percentage of participants	—

SECONDARY outcome

Timeframe: 8 weeks

Population: All 60 subjects randomized to both sets of lenses.

Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Recommendation of a Study Lens to Friends, Family or Colleagues	77 percentage of participants	23 percentage of participants	—

SECONDARY outcome

Timeframe: 8 weeks

Population: All 60 subjects randomized to both sets of lenses.

Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. Very Likely	52 percentage of participants	15 percentage of participants	—
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. Likely	35 percentage of participants	40 percentage of participants	—
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. Unlikely	11 percentage of participants	35 percentage of participants	—
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. Very Unlikely	2 percentage of participants	10 percentage of participants	—

SECONDARY outcome

Timeframe: 8 weeks

Population: All 60 subjects wore habitual lenses prior to randomization of study lenses.

Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Comfort	72 percentage of participants	15 percentage of participants	13 percentage of participants
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Dryness	68 percentage of participants	17 percentage of participants	15 percentage of participants
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Handling	27 percentage of participants	42 percentage of participants	31 percentage of participants
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Lens Fit	47 percentage of participants	42 percentage of participants	11 percentage of participants
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Vision	60 percentage of participants	30 percentage of participants	10 percentage of participants
Participant Preference for Their Habitual Lenses or Either of the Study Lenses Overall	65 percentage of participants	23 percentage of participants	12 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All 60 subjects wore habitual lenses prior to randomization of study lenses.

Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; first study lenses, second study lenses, neither)

Outcome measures

Outcome measures
Measure	Comfilcon A n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Lotrafilcon B n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.	Habitual n=60 Participants All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
Participant Preference for Either of the Study Lenses Comfort	80 percentage of participants	20 percentage of participants	0 percentage of participants
Participant Preference for Either of the Study Lenses Dryness	80 percentage of participants	20 percentage of participants	0 percentage of participants
Participant Preference for Either of the Study Lenses Handling	40 percentage of participants	55 percentage of participants	5 percentage of participants
Participant Preference for Either of the Study Lenses Lens Fit	58 percentage of participants	38 percentage of participants	4 percentage of participants
Participant Preference for Either of the Study Lenses Vision	70 percentage of participants	28 percentage of participants	2 percentage of participants
Participant Preference for Either of the Study Lenses Overall	78 percentage of participants	22 percentage of participants	0 percentage of participants

Adverse Events

Comfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose A. Vega Sr. Mgr. Global Medical Scientific Affairs

CooperVision

Phone: (925) 621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
Publication restrictions are in place

Restriction type: OTHER