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Trial Outcomes & Findings for Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (NCT NCT04529109)

NCT ID: NCT04529109

Last Updated: 2021-11-24

Results Overview

Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

5- Minutes Post-Lens Fitting

Results posted on

2021-11-24

Participant Flow

A total of 58 subjects were enrolled into this study. Of those enrolled, 56 were dispensed at least 1 study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 55 subjects completed the study while 1 subject was discontinued.

Participant milestones

Participant milestones
Measure
Test/Control
Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
Control/Test
Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
Period 1
STARTED
27
29
Period 1
COMPLETED
27
28
Period 1
NOT COMPLETED
0
1
Period 2
STARTED
27
28
Period 2
COMPLETED
27
28
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Test/Control
Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
Control/Test
Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
Period 1
Unsatisfactory Lens Fitting due to Test Article
0
1

Baseline Characteristics

Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total
n=56 Participants
All subjects who were dispensed a study lens.
Age, Continuous
23.1 years
STANDARD_DEVIATION 2.42 • n=5 Participants
Sex: Female, Male
Female
56 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
41 participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
1 participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
4 participants
n=5 Participants
Race/Ethnicity, Customized
White
9 participants
n=5 Participants
Race/Ethnicity, Customized
Other
1 participants
n=5 Participants
Region of Enrollment
United States
17 participants
n=5 Participants
Region of Enrollment
China
39 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5- Minutes Post-Lens Fitting

Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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

Outcome measures
Measure
Test (Etafilcon A With Cosmetic Pattern)
n=102 Eyes
Subjects that wore the Test lens in either the first or second period of the study.
Control (Etafilcon A With Cosmetic Pattern)
n=102 Eyes
Subjects that wore the Control lens in either the first or second period of the study.
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR
0.9998 proportion of eyes
0.9998 proportion of eyes

Adverse Events

Test (Etafilcon A With Cosmetic Pattern)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control (Etafilcon A With Cosmetic Pattern)

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

Meredith Bishop, OD, MS, FAAO-Sr. Principal Research Optometrist

Johnson & Johnson Vision Care

Phone: 904-443-1783

Results disclosure agreements

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

Restriction type: GT60