Trial Outcomes & Findings for Clinical Evaluation of Two Cosmetic Contact Lenses (NCT NCT06864858)
NCT ID: NCT06864858
Last Updated: 2026-05-29
Results Overview
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
COMPLETED
NA
53 participants
Fitting Evaluation
2026-05-29
Participant Flow
A total of 53 subjects were enrolled in this study. All 53 enrolled subjects met all eligibility criteria and completed the study.
Participant milestones
| Measure |
Test (Etafilcon A)/Control (Etafilcon A)
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
|
Control (Etafilcon A)/Test (Etafilcon A)
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
|
|---|---|---|
|
Period 1
STARTED
|
26
|
27
|
|
Period 1
COMPLETED
|
26
|
27
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
26
|
27
|
|
Period 2
COMPLETED
|
26
|
27
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Two Cosmetic Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Reporting Group
n=53 Participants
All subjects dispensed at least one study contact lens.
|
|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 5.36 • n=51 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Fitting EvaluationPopulation: All subjects dispensed at least one study contact lens. All subjects who successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review prior to database lock.
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Outcome measures
| Measure |
Test (Etafilcon A)
n=106 Eyes
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=106 Eyes
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Distance Monocular logMAR Visual Acuity
|
-0.159 logMAR
Standard Deviation 0.0665
|
-0.157 logMAR
Standard Deviation 0.0740
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place