Trial Outcomes & Findings for Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear (NCT NCT04050618)

Results Overview

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Two weeks

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ocufilcon D Control Lens, Then Fanfilcon A Test Lens Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. ocufilcon D control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens	Etafilcon A Controls, Then Fanfilcon A Test Lens Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. etafilcon A control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens
First Intervention STARTED	58	56
First Intervention COMPLETED	56	56
First Intervention NOT COMPLETED	2	0
Second Intervention STARTED	56	56
Second Intervention COMPLETED	55	56
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocufilcon D Control Lens, Then Fanfilcon A Test Lens Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. ocufilcon D control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens	Etafilcon A Controls, Then Fanfilcon A Test Lens Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. etafilcon A control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens
First Intervention Withdrawal by Subject	2	0
Second Intervention Withdrawal by Subject	1	0

Baseline Characteristics

Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocufilcon D Control Lens, Then Fanfilcon A Test Lens n=58 Participants Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. ocufilcon D control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens	Etafilcon A Controls, Then Fanfilcon A Test Lens n=56 Participants Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. etafilcon A control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens	Total n=114 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	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.4 years STANDARD_DEVIATION 9.42 • n=5 Participants	32.7 years STANDARD_DEVIATION 9.00 • n=7 Participants	33.1 years STANDARD_DEVIATION 9.18 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	52 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	56 participants n=7 Participants	114 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=57 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=56 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=56 Participants Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=56 Participants Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Subjective Overall Comfort Rating	8.2 units on a scale Standard Deviation 2.04	8.6 units on a scale Standard Deviation 1.19	8.3 units on a scale Standard Deviation 1.72	8.3 units on a scale Standard Deviation 1.64

PRIMARY outcome

Timeframe: Four weeks

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=56 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=55 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Subjective Overall Comfort Rating	7.9 units on a scale Standard Deviation 2.10	8.6 units on a scale Standard Deviation 1.26	—	—

SECONDARY outcome

Timeframe: Two weeks

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=57 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=56 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=56 Participants Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=56 Participants Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Average Wearing Time	14.01 hours/day Standard Deviation 1.689	14.7 hours/day Standard Deviation 1.674	13.84 hours/day Standard Deviation 1.756	13.80 hours/day Standard Deviation 1.757

SECONDARY outcome

Timeframe: Four weeks

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=56 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=55 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Average Wearing Time	14.21 hours/day Standard Deviation 1.501	14.42 hours/day Standard Deviation 1.504	—	—

SECONDARY outcome

Timeframe: Two weeks

Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=57 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=56 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=56 Participants Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=56 Participants Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Average Comfortable Wearing Time	11.60 hours/day Standard Deviation 3.743	12.45 hours/day Standard Deviation 3.669	12.18 hours/day Standard Deviation 3.210	11.67 hours/day Standard Deviation 3.330

SECONDARY outcome

Timeframe: Four weeks

Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=56 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=55 Participants Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Average Comfortable Wearing Time	11.37 hours/day Standard Deviation 3.869	12.40 hours/day Standard Deviation 3.379	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes)

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Centration Optimal	85 percentage of eyes	93 percentage of eyes	91 percentage of eyes	94 percentage of eyes
Lens Centration Slight	15 percentage of eyes	7 percentage of eyes	9 percentage of eyes	6 percentage of eyes
Lens Centration Substantial	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Two weeks

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Centration Optimal	88 percentage of eyes	93 percentage of eyes	83 percentage of eyes	95 percentage of eyes
Lens Centration Slight	12 percentage of eyes	7 percentage of eyes	17 percentage of eyes	5 percentage of eyes
Lens Centration Substantial	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Four weeks

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Centration Optimal	86 percentage of eyes	89 percentage of eyes	—	—
Lens Centration Slight	14 percentage of eyes	11 percentage of eyes	—	—
Lens Centration Substantial	0 percentage of eyes	0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Corneal Coverage yes	100 percentage of eyes	100 percentage of eyes	100 percentage of eyes	100 percentage of eyes
Corneal Coverage no	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Two weeks

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Corneal Coverage yes	98 percentage of eyes	98 percentage of eyes	100 percentage of eyes	100 percentage of eyes
Corneal Coverage no	2 percentage of eyes	2 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Four weeks

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Corneal Coverage yes	100 percentage of eyes	98 percentage of eyes	—	—
Corneal Coverage no	0 percentage of eyes	2 percentage of eyes	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Post-Blink Movement Insufficient	0 percentage of eyes	0 percentage of eyes	2 percentage of eyes	0 percentage of eyes
Post-Blink Movement Minimal	4 percentage of eyes	0 percentage of eyes	9 percentage of eyes	5 percentage of eyes
Post-Blink Movement Optimal	91 percentage of eyes	94 percentage of eyes	84 percentage of eyes	82 percentage of eyes
Post-Blink Movement Moderate	5 percentage of eyes	6 percentage of eyes	5 percentage of eyes	13 percentage of eyes
Post-Blink Movement Excessive	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Two weeks

Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Post-Blink Movement Excessive	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Post-Blink Movement Insufficient	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Post-Blink Movement Minimal	4 percentage of eyes	0 percentage of eyes	11 percentage of eyes	5 percentage of eyes
Post-Blink Movement Optimal	91 percentage of eyes	98 percentage of eyes	83 percentage of eyes	91 percentage of eyes
Post-Blink Movement Moderate	5 percentage of eyes	2 percentage of eyes	6 percentage of eyes	4 percentage of eyes

SECONDARY outcome

Timeframe: Four weeks

Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Post-Blink Movement Insufficient	0 percentage of eyes	0 percentage of eyes	—	—
Post-Blink Movement Minimal	4 percentage of eyes	2 percentage of eyes	—	—
Post-Blink Movement Optimal	80 percentage of eyes	96 percentage of eyes	—	—
Post-Blink Movement Moderate	16 percentage of eyes	2 percentage of eyes	—	—
Post-Blink Movement Excessive	0 percentage of eyes	0 percentage of eyes	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Tightness - Push-up Test	49.6 percentage of eyes Standard Deviation 5.36	49.0 percentage of eyes Standard Deviation 3.80	52.1 percentage of eyes Standard Deviation 8.26	50.2 percentage of eyes Standard Deviation 5.69

SECONDARY outcome

Timeframe: Two weeks

Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Tightness - Push-up Test	49.7 percentage of eyes Standard Deviation 4.12	48.4 percentage of eyes Standard Deviation 4.55	50.6 percentage of eyes Standard Deviation 5.88	48.0 percentage of eyes Standard Deviation 7.95

SECONDARY outcome

Timeframe: Four weeks

Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Lens Tightness - Push-up Test	48.4 percentage of eyes Standard Deviation 5.62	49.8 percentage of eyes Standard Deviation 3.67	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Overall Lens Fit Acceptance Should not be worn	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance Borderline	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance Minimal	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance OK	22 percentage of eyes	9 percentage of eyes	18 percentage of eyes	21 percentage of eyes
Overall Lens Fit Acceptance Perfect	78 percentage of eyes	91 percentage of eyes	82 percentage of eyes	79 percentage of eyes

SECONDARY outcome

Timeframe: Two weeks

Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Overall Lens Fit Acceptance Should not be worn	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance Borderline	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance Minimal	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Lens Fit Acceptance OK	16 percentage of eyes	12 percentage of eyes	26 percentage of eyes	13 percentage of eyes
Overall Lens Fit Acceptance Perfect	84 percentage of eyes	88 percentage of eyes	74 percentage of eyes	88 percentage of eyes

SECONDARY outcome

Timeframe: Four weeks

Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Overall Lens Fit Acceptance Should not be worn	0 percentage of eyes	0 percentage of eyes	—	—
Overall Lens Fit Acceptance Borderline	0 percentage of eyes	0 percentage of eyes	—	—
Overall Lens Fit Acceptance Minimal	0 percentage of eyes	0 percentage of eyes	—	—
Overall Lens Fit Acceptance OK	23 percentage of eyes	15 percentage of eyes	—	—
Overall Lens Fit Acceptance Perfect	77 percentage of eyes	85 percentage of eyes	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Rating of Lens Surface Wettability	3.93 units on a scale Standard Deviation 0.266	3.96 units on a scale Standard Deviation 0.172	3.94 units on a scale Standard Deviation 0.286	3.92 units on a scale Standard Deviation 0.265

SECONDARY outcome

Timeframe: Two weeks

Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=57 Participants Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Rating of Lens Surface Wettability	3.74 units on a scale Standard Deviation 0.490	3.69 units on a scale Standard Deviation 0.512	3.73 units on a scale Standard Deviation 0.611	3.80 units on a scale Standard Deviation 0.437

SECONDARY outcome

Timeframe: Four weeks

Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Rating of Lens Surface Wettability	3.55 units on a scale Standard Deviation 0.736	3.81 units on a scale Standard Deviation 0.365	—	—

SECONDARY outcome

Timeframe: Two weeks

Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Presence of Film Deposits Grade 0	85 percentage of eyes	86 percentage of eyes	85 percentage of eyes	86 percentage of eyes
Presence of Film Deposits Grade 1	12 percentage of eyes	13 percentage of eyes	13 percentage of eyes	13 percentage of eyes
Presence of Film Deposits Grade 2	3 percentage of eyes	2 percentage of eyes	2 percentage of eyes	2 percentage of eyes
Presence of Film Deposits Grade 3	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Presence of Film Deposits Grade 4	0 percentage of eyes	0 percentage of eyes	1 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Four weeks

Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Presence of Film Deposits Grade 0	74 percentage of eyes	79 percentage of eyes	—	—
Presence of Film Deposits Grade 1	22 percentage of eyes	17 percentage of eyes	—	—
Presence of Film Deposits Grade 2	2 percentage of eyes	2 percentage of eyes	—	—
Presence of Film Deposits Grade 3	0 percentage of eyes	0 percentage of eyes	—	—
Presence of Film Deposits Grade 4	2 percentage of eyes	2 percentage of eyes	—	—

SECONDARY outcome

Timeframe: Two weeks

Number of white spot deposits assessed using slit lamp with white light, low medium magnification

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Number of White Spot Deposits	0.01 number of white spots Standard Deviation 0.094	0.05 number of white spots Standard Deviation 0.567	0.03 number of white spots Standard Deviation 0.211	0.22 number of white spots Standard Deviation 1.145

SECONDARY outcome

Timeframe: Four weeks

Number of white spot deposits assessed using slit lamp with white light, low medium magnification

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=112 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=110 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Number of White Spot Deposits	0.15 number of white spots Standard Deviation 0.988	0.18 number of white spots Standard Deviation 0.940	—	—

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=116 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Primary Gaze Lag Insufficient	0 eyes	0 eyes	2 eyes	0 eyes
Primary Gaze Lag Minimal	5 eyes	0 eyes	8 eyes	6 eyes
Primary Gaze Lag Optimal	107 eyes	106 eyes	100 eyes	93 eyes
Primary Gaze Lag Moderate	4 eyes	6 eyes	2 eyes	13 eyes
Primary Gaze Lag Excessive	0 eyes	0 eyes	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Two weeks

Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)

Outcome measures

Outcome measures
Measure	Ocufilcon D - Group A n=114 eyes Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens	Fanfilcon A - Group A n=112 eyes Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens	Etafilcon A - Group B n=112 eyes Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens	Fanfilcon A - Group B n=112 eyes Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens
Primary Gaze Lag Insufficient	0 eyes	0 eyes	0 eyes	0 eyes
Primary Gaze Lag Minimal	2 eyes	0 eyes	8 eyes	2 eyes
Primary Gaze Lag Optimal	108 eyes	109 eyes	97 eyes	108 eyes
Primary Gaze Lag Moderate	4 eyes	3 eyes	7 eyes	2 eyes
Primary Gaze Lag Excessive	0 eyes	0 eyes	0 eyes	0 eyes

SECONDARY outcome

Timeframe: Four weeks

Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)