Trial Outcomes & Findings for Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses (NCT NCT04534764)

Last Updated: 2021-09-01

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. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

5 min post lens insertion

Results posted on

2021-09-01

Participant Flow

A total of 35 subjects were enrolled in this study. Of those enrolled, all 35 subjects were dispensed both study lenses and completed the study.

Participant milestones

Participant milestones
Measure	Test/Control Subjects randomized to receive the Test lens during the first period and then received the Control lens during the second period.	Control/Test Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period.
Period 1 STARTED	18	17
Period 1 COMPLETED	18	17
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	18	17
Period 2 COMPLETED	18	17
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=35 Participants All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Age, Continuous	30.2 years STANDARD_DEVIATION 5.36 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants
Race/Ethnicity, Customized White	32 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 min post lens insertion

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

Outcome measures

Outcome measures
Measure	Test n=70 Eyes Subjects that wore the Test lens in either the first or second period of the study.	Control n=70 Eyes Subjects that wore the Control lens in either the first or second period of the study.
Distance Monocular Visual Acuity (logMAR) High Luminance Low Contrast	-0.016 logMAR Standard Deviation 0.1083	-0.001 logMAR Standard Deviation 0.1046
Distance Monocular Visual Acuity (logMAR) High Luminance High Contrast	-0.171 logMAR Standard Deviation 0.0857	-0.151 logMAR Standard Deviation 0.0852
Distance Monocular Visual Acuity (logMAR) Low Luminance High Contrast	0.016 logMAR Standard Deviation 0.1008	0.007 logMAR Standard Deviation 0.0814

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60