Trial Outcomes & Findings for Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022) (NCT NCT05480514)
NCT ID: NCT05480514
Last Updated: 2024-01-03
Results Overview
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
COMPLETED
NA
89 participants
5-minutes post-lens-fitting
2024-01-03
Participant Flow
A total of 89 subjects were enrolled in this study. Of those enrolled, 77 subjects were dispensed at least one study lens. Of those dispensed, 54 subjects completed the study while 23 subjects were discontinued.
Participant milestones
| Measure |
Test [Etafilcon A] \ Control [Etafilcon A]
Subjects in this sequence were randomized to receive the Test \[etafilcon A\] lens during the first period and the Control \[etafilcon A\] lens during the second period.
|
Control [Etafilcon A] \ Test [Etafilcon A]
Subjects in this sequence were randomized to receive the Control \[etafilcon A\] lens during the first period and the Test \[etafilcon A\] lens during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
38
|
39
|
|
Period 1
COMPLETED
|
32
|
30
|
|
Period 1
NOT COMPLETED
|
6
|
9
|
|
Period 2
STARTED
|
32
|
30
|
|
Period 2
COMPLETED
|
28
|
26
|
|
Period 2
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Test [Etafilcon A] \ Control [Etafilcon A]
Subjects in this sequence were randomized to receive the Test \[etafilcon A\] lens during the first period and the Control \[etafilcon A\] lens during the second period.
|
Control [Etafilcon A] \ Test [Etafilcon A]
Subjects in this sequence were randomized to receive the Control \[etafilcon A\] lens during the first period and the Test \[etafilcon A\] lens during the second period.
|
|---|---|---|
|
Period 1
Pd-Incorrect Lens Power Assigned
|
2
|
3
|
|
Period 1
Unsatisfactory Lens Fitting Due to Test Article
|
3
|
5
|
|
Period 1
Subject No Longer Meets Eligibility Criteria
|
0
|
1
|
|
Period 1
Covid-19 Related
|
1
|
0
|
|
Period 2
Unsatisfactory Lens Fitting Due to Test Article
|
4
|
4
|
Baseline Characteristics
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=77 Participants
All subjects dispensed one study lens.
|
|---|---|
|
Age, Continuous
|
24.4 Years
STANDARD_DEVIATION 2.51 • n=99 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
77 Participants
n=99 Participants
|
|
Region of Enrollment
Hong Kong, S.A.R., China
|
77 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5-minutes post-lens-fittingPopulation: All subject dispensed at least one study lens.
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Outcome measures
| Measure |
Test [Etafilcon A]
n=136 Eyes
Subjects that wore the Test \[etafilcon A\] lens during any of the two study periods.
|
Control [Etafilcon A]
n=142 Eyes
Subjects that wore the Control \[etafilcon A\] lens during any of the two study periods.
|
|---|---|---|
|
Proportion of Eyes With LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity)
|
1 Proportion of eyes
|
1 Proportion of eyes
|
Adverse Events
Test [Etafilcon A]
Control [Etafilcon A]
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60