Trial Outcomes & Findings for A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses (NCT NCT03235089)

Results Overview

Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Baseline

Results posted on

2020-10-14

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Test Lens Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Overall Study STARTED	31 31	31 31
Overall Study COMPLETED	28 28	28 28
Overall Study NOT COMPLETED	3 3	3 3

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Lens Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=28 Participants Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours.
Age, Categorical <=18 years	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants
Age, Continuous	29 years STANDARD_DEVIATION 9 • n=28 Participants
Sex: Female, Male Female	19 Participants n=28 Participants
Sex: Female, Male Male	9 Participants n=28 Participants
Region of Enrollment United States	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Baseline

Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Horizontal Lens Centration Assessed in Primary Gaze	-0.13 millimeters Standard Deviation 0.20	-0.04 millimeters Standard Deviation 0.21

PRIMARY outcome

Timeframe: 6-hour

Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Horizontal Lens Centration Assessed in Primary Gaze	-0.15 millimeters Standard Deviation 0.20	-0.06 millimeters Standard Deviation 0.16

PRIMARY outcome

Timeframe: Baseline

Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Vertical Lens Centration Assessed in Primary Gaze	0.17 millimeters Standard Deviation 0.25	0.06 millimeters Standard Deviation 0.20

PRIMARY outcome

Timeframe: 6-hours

Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Vertical Lens Centration Assessed in Primary Gaze	0.10 millimeters Standard Deviation 0.22	-0.03 millimeters Standard Deviation 0.25

PRIMARY outcome

Timeframe: Baseline

Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Lens Tightness Assessed by Push-up Test	38 units on a scale Standard Deviation 7	41 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: 6-hours

Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Lens Tightness Assessed by Push-up Test	41 units on a scale Standard Deviation 8	49 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: Baseline

Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule	0.16 millimeters Standard Deviation 0.06	0.13 millimeters Standard Deviation 0.05

PRIMARY outcome

Timeframe: 6 hours

Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule	0.18 millimeters Standard Deviation 0.08	0.12 millimeters Standard Deviation 0.04

PRIMARY outcome

Timeframe: Baseline

Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	3.1 millimeters Standard Deviation 0.3	2.7 millimeters Standard Deviation 0.3

PRIMARY outcome

Timeframe: 6 hours

Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	3.0 millimeters Standard Deviation 0.3	2.7 millimeters Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline

Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Overall Lens Fit Acceptance	2.7 units on a scale Standard Deviation 0.6	3.1 units on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: 6 hours

Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Overall Lens Fit Acceptance	2.7 units on a scale Standard Deviation 0.5	3.0 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline

Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Up Gaze Lag Assessed Observing Lens Movement in Graticule	0.41 millimeters Standard Deviation 0.18	0.38 millimeters Standard Deviation 0.16

PRIMARY outcome

Timeframe: 6 hours

Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Up Gaze Lag Assessed Observing Lens Movement in Graticule	0.34 millimeters Standard Deviation 0.11	0.35 millimeters Standard Deviation 0.14

PRIMARY outcome

Timeframe: Baseline

Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	0.44 millimeters Standard Deviation 0.14	0.31 millimeters Standard Deviation 0.11

PRIMARY outcome

Timeframe: 6 hours

Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

Outcome measures

Outcome measures
Measure	Test Lens n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Test Lens: Daily disposable contact lens	Nelfilcon A Lens (Control) n=28 Eyes Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule. Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	0.43 millimeters Standard Deviation 0.17	0.29 millimeters Standard Deviation 0.11

Adverse Events

Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A Lens ( Control)

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

Lee Hall, BSc, PhD, MCOptom, FBCLA

CooperVision, Inc

Phone: 925 251 6684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place