Trial Outcomes & Findings for A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens. (NCT NCT03951610)

NCT ID: NCT03951610

Last Updated: 2020-06-18

Results Overview

Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-06-18

Participant Flow

Participant milestones

Measure	Test Lens Then Control Lens Subjects were randomized to wear the test lens for one week then the control lens for one week. Test lens: contact lens	Control Lens Then Test Lens Subjects were randomized to wear the control lens for one week then the test lens for one week. Control lens: contact lens
First Intervention STARTED	27	25
First Intervention COMPLETED	27	25
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	27	25
Second Intervention COMPLETED	27	25
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=52 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=52 Participants
Age, Categorical >=65 years	0 Participants n=52 Participants
Age, Continuous	27 years STANDARD_DEVIATION 6 • n=52 Participants
Sex: Female, Male Female	34 Participants n=52 Participants
Sex: Female, Male Male	18 Participants n=52 Participants
Region of Enrollment United States	52 participants n=52 Participants

PRIMARY outcome

Timeframe: Baseline

Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Number of Participants With Lens Centration Optimal	17 Participants	12 Participants
Number of Participants With Lens Centration Slightly Decentered	34 Participants	39 Participants
Number of Participants With Lens Centration Extreme Decentered	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 1 week

Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Number of Participants With Lens Centration Optimal	20 Participants	16 Participants
Number of Participants With Lens Centration Slightly Decentered	31 Participants	36 Participants
Number of Participants With Lens Centration Extreme Decentered	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Post Blink Movement	0.25 millimeters (mm) Standard Deviation 0.10	0.26 millimeters (mm) Standard Deviation 0.09

PRIMARY outcome

Timeframe: 1 week

Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Post Blink Movement	0.26 millimeters (mm) Standard Deviation 0.12	0.25 millimeters (mm) Standard Deviation 0.12

PRIMARY outcome

Timeframe: baseline

Primary Gaze Lag (measured in mm at 0.1mm steps)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Primary Gaze Lag	0.22 millimeters (mm) Standard Deviation 0.12	0.25 millimeters (mm) Standard Deviation 0.16

PRIMARY outcome

Timeframe: 1 week

Primary Gaze Lag (measured in mm at 0.1mm steps)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Primary Gaze Lag	0.23 millimeters (mm) Standard Deviation 0.12	0.22 millimeters (mm) Standard Deviation 0.15

PRIMARY outcome

Timeframe: Baseline

Up Gaze Lag (measured in mm at 0.1mm steps)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Up Gaze Lag	0.28 millimeters (mm) Standard Deviation 0.10	0.31 millimeters (mm) Standard Deviation 0.12

PRIMARY outcome

Timeframe: 1 week

Up Gaze Lag (measured in mm at 0.1mm steps)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Up Gaze Lag	0.28 millimeters (mm) Standard Deviation 0.12	0.29 millimeters (mm) Standard Deviation 0.20

PRIMARY outcome

Timeframe: baseline

Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Push-Up Tightness	46 percentage Standard Deviation 6	47 percentage Standard Deviation 4

PRIMARY outcome

Timeframe: 1 week

Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Push-Up Tightness	45 percentage Standard Deviation 6	48 percentage Standard Deviation 9

PRIMARY outcome

Timeframe: Baseline

Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Overall Fit Acceptance	3.12 units on a scale Standard Deviation 0.39	3.08 units on a scale Standard Deviation 0.36

PRIMARY outcome

Timeframe: 1 week

Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Overall Fit Acceptance	3.12 units on a scale Standard Deviation 0.41	3.13 units on a scale Standard Deviation 0.44

PRIMARY outcome

Timeframe: Baseline

Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Number of Participants With Overall Lens Fit Impression Reduced Unacceptable	0 Participants	0 Participants
Number of Participants With Overall Lens Fit Impression Reduced Acceptable	7 Participants	7 Participants
Number of Participants With Overall Lens Fit Impression Optimal	43 Participants	44 Participants
Number of Participants With Overall Lens Fit Impression Excessive Acceptable	2 Participants	1 Participants
Number of Participants With Overall Lens Fit Impression Excessive Unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 week

Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Number of Participants With Overall Lens Fit Impression Reduced Unacceptable	0 Participants	1 Participants
Number of Participants With Overall Lens Fit Impression Reduced Acceptable	9 Participants	9 Participants
Number of Participants With Overall Lens Fit Impression Optimal	41 Participants	41 Participants
Number of Participants With Overall Lens Fit Impression Excessive Acceptable	2 Participants	1 Participants
Number of Participants With Overall Lens Fit Impression Excessive Unacceptable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Subjective Comfort Rating	9.0 units on a scale Standard Deviation 1.2	9.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1-week

Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

Outcome measures

Measure	Test Lens n=52 Participants Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Control Lens n=52 Participants Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Subjective Comfort Rating	9.1 units on a scale Standard Deviation 1.1	9.1 units on a scale Standard Deviation 1.0

Adverse Events

Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Lens

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

Myhanh Nguyen

CooperVision, Inc.

Phone: 925-730-6716

Email: mnguyen@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place