Trial Outcomes & Findings for Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control (NCT NCT04709237)

NCT ID: NCT04709237

Last Updated: 2024-08-27

Results Overview

Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2024-08-27

Participant Flow

Participant milestones

Measure	Omafilcon A Control Lens First, Then Omafilcon A Test Lens 1, Then Omafilcon A Test Lens 2 Participants first wore omafilcon A control lens first, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.	Omafilcon A Test Lens 2 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 1 Participants first wore omafilcon A test lens 1, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.	Omafilcon A Test Lens 1 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 2 Participants first wore omafilcon A test lens 2, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.
Overall Study STARTED	7	7	7
Overall Study COMPLETED	6	7	7
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Omafilcon A Control Lens First, Then Omafilcon A Test Lens 1, Then Omafilcon A Test Lens 2 Participants first wore omafilcon A control lens first, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.	Omafilcon A Test Lens 2 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 1 Participants first wore omafilcon A test lens 1, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.	Omafilcon A Test Lens 1 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 2 Participants first wore omafilcon A test lens 2, followed by the other 2 study contact lenses in a randomized order. Each study lens was worn for 10 days.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=19 Participants Nineteen total participants were analyzed out of the 20 participants who completed the study.
Age, Continuous	14.4 Years STANDARD_DEVIATION 1.9 • n=19 Participants
Sex: Female, Male Female	11 Participants n=19 Participants
Sex: Female, Male Male	8 Participants n=19 Participants

PRIMARY outcome

Timeframe: 10 days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Overall Vision Satisfaction	87.7 units on a scale Standard Deviation 12.1	79.7 units on a scale Standard Deviation 16.5	71.8 units on a scale Standard Deviation 27.3

PRIMARY outcome

Timeframe: 10 days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Habitual daily wearing time in hours

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Habitual Daily Wearing Time	7.9 Hours/Day Standard Deviation 2.0	8.1 Hours/Day Standard Deviation 2.2	7.8 Hours/Day Standard Deviation 2.3

SECONDARY outcome

Timeframe: 10 days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Visual acuity measured using logMAR

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Visual Acuity	0.06 logMAR Standard Deviation 0.07	0.08 logMAR Standard Deviation 0.07	0.10 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 10 days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Overall Visual Satisfaction During the Use of iPad With White Screen	90.8 units on a scale Standard Deviation 9.3	90.8 units on a scale Standard Deviation 10.0	85.1 units on a scale Standard Deviation 16.2

SECONDARY outcome

Timeframe: 10 Days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.	90.7 units on a scale Standard Deviation 9.5	90.0 units on a scale Standard Deviation 13.3	84.4 units on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: 10 Days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.	85.4 units on a scale Standard Deviation 16.1	86.8 units on a scale Standard Deviation 15.7	80.0 units on a scale Standard Deviation 20.0

SECONDARY outcome

Timeframe: 10 Days

Population: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)

Outcome measures

Measure	Omafilcon A Control Lens n=19 Participants Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 Participants Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 Participants Participants wore omafilcon A Test Lens 2 during the study.
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.	85.3 units on a scale Standard Deviation 14.0	87.5 units on a scale Standard Deviation 15.1	79.2 units on a scale Standard Deviation 22.3

Adverse Events

Omafilcon A Control Lens

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Omafilcon A Test Lens 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon A Test Lens 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omafilcon A Control Lens n=19 participants at risk Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 participants at risk Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 participants at risk Participants wore omafilcon A Test Lens 2 during the study.
Product Issues Headache	0.00% 0/19 • Duration of all three study lens wear for approximately 30 days.	0.00% 0/19 • Duration of all three study lens wear for approximately 30 days.	0.00% 0/19 • Duration of all three study lens wear for approximately 30 days.

Other adverse events

Measure	Omafilcon A Control Lens n=19 participants at risk Participants wore omafilcon A Control Lens during the study.	Omafilcon A Test Lens 1 n=19 participants at risk Participants wore omafilcon A Test Lens 1 during the study.	Omafilcon A Test Lens 2 n=19 participants at risk Participants wore omafilcon A Test Lens 2 during the study.
General disorders Headache	10.5% 2/19 • Number of events 2 • Duration of all three study lens wear for approximately 30 days.	0.00% 0/19 • Duration of all three study lens wear for approximately 30 days.	0.00% 0/19 • Duration of all three study lens wear for approximately 30 days.

Additional Information

Paul Chamberlain

Coopervision

Phone: 925-251-6682

Email: PChamberlain@coopervision.com

Results disclosure agreements

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

Restriction type: OTHER