Trial Outcomes & Findings for Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers (NCT NCT04831515)

NCT ID: NCT04831515

Last Updated: 2022-02-15

Results Overview

Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2022-02-15

Participant Flow

Participant milestones

Measure	Lens A, Then Lens B Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens	Lens B, Then Lens A Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens
First Intervention STARTED	24	24
First Intervention COMPLETED	24	23
First Intervention NOT COMPLETED	0	1
Second Intervention STARTED	24	23
Second Intervention COMPLETED	24	23
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Lens A, Then Lens B Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens	Lens B, Then Lens A Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens
First Intervention Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=48 Participants daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens
Age, Categorical <=18 years	0 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=48 Participants
Age, Categorical >=65 years	0 Participants n=48 Participants
Age, Continuous	32.5 years STANDARD_DEVIATION 6.8 • n=48 Participants
Sex: Female, Male Female	34 Participants n=48 Participants
Sex: Female, Male Male	14 Participants n=48 Participants
Region of Enrollment United States	48 participants n=48 Participants

PRIMARY outcome

Timeframe: 1 week

Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

Outcome measures

Measure	Lens A n=47 Participants Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens	Lens B n=47 Participants Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens
Overall Ease of Lens Handling	9.0 units on a scale Standard Deviation 1.1	8.8 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline - after lenses have settled for 10 minutes

Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

Outcome measures

Measure	Lens A n=47 Participants Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens	Lens B n=47 Participants Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens
Visual Acuity	-0.06 logMAR Standard Deviation 0.06	-0.06 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 1 week

Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

Outcome measures

Measure	Lens A n=47 Participants Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens	Lens B n=47 Participants Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens
Visual Acuity	-0.06 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.06

Adverse Events

Lens A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lens B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lens A n=48 participants at risk Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens	Lens B n=48 participants at risk Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens
Eye disorders inferior single corneal peripheral ulcer	0.00% 0/48 • From dispense up to 1 week on each study lenses for a total of 2 weeks	2.1% 1/48 • Number of events 1 • From dispense up to 1 week on each study lenses for a total of 2 weeks

Additional Information

Jose A. Vega, O.D., MSc, FAAO

Coopervision

Phone: 9256213761

Email: JVega2@coopervision.com

Results disclosure agreements

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