Trial Outcomes & Findings for Objective Vision Evaluation of Two Cosmetic Contact Lenses (NCT NCT04287036)

Last Updated: 2025-04-27

Results Overview

Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

20- Minutes Post-Lens Fitting

Results posted on

2025-04-27

Participant Flow

A total of 28 subjects were enrolled into this study. Of those enrolled 25 were dispensed study lenses and completed the study, while 3 subjects failed to meet all eligibility criteria.

Participant milestones

Participant milestones
Measure	Test/Control Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.	Control/Test 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	13	12
Period 1 COMPLETED	13	12
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	13	12
Period 2 COMPLETED	13	12
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Objective Vision Evaluation of Two Cosmetic Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=25 Participants All subjects who were dispensed a study lens.
Age, Continuous	26.1 years STANDARD_DEVIATION 4.39 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 20- Minutes Post-Lens Fitting

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

Outcome measures

Outcome measures
Measure	Test n=25 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=25 Participants Subjects that wore the Control lens in either the first or second period of the study.
Distance Binocular Visual Acuity (logMAR) High Luminance High Contrast	-0.15 logMAR Standard Deviation 0.074	-0.18 logMAR Standard Deviation 0.069
Distance Binocular Visual Acuity (logMAR) High Luminance Low Contrast	0.00 logMAR Standard Deviation 0.083	-0.04 logMAR Standard Deviation 0.070
Distance Binocular Visual Acuity (logMAR) Low Luminance High Contrast with goggles	0.02 logMAR Standard Deviation 0.094	0.01 logMAR Standard Deviation 0.065

PRIMARY outcome

Timeframe: 20- 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 near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles 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 value of 0.0 is equivalent to 20/20 Snellen vision.

Outcome measures

Outcome measures
Measure	Test n=25 Participants Subjects that wore the Test lens in either the first or second period of the study.	Control n=25 Participants Subjects that wore the Control lens in either the first or second period of the study.
Near BinocularVisual Acuity (logMAR) High Luminance Low Contrast	0.04 logMAR Standard Deviation 0.070	0.02 logMAR Standard Deviation 0.076
Near BinocularVisual Acuity (logMAR) Low Luminance High Contrast with goggles	-0.02 logMAR Standard Deviation 0.072	-0.04 logMAR Standard Deviation 0.064

PRIMARY outcome

Timeframe: 20- Minutes Post-Lens Fitting

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

Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision.

Outcome measures

Outcome measures
Measure	Test n=50 eyes Subjects that wore the Test lens in either the first or second period of the study.	Control n=50 eyes Subjects that wore the Control lens in either the first or second period of the study.
Quantitative Visual Acuity Right Eye	0.061 logMAR Standard Deviation 0.0889	0.051 logMAR Standard Deviation 0.0749
Quantitative Visual Acuity Both Eyes	-0.010 logMAR Standard Deviation 0.0578	-0.039 logMAR Standard Deviation 0.0645

PRIMARY outcome

Timeframe: 20- Minutes Post-Lens Fitting

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

Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured.

Outcome measures

Outcome measures
Measure	Test n=50 eyes Subjects that wore the Test lens in either the first or second period of the study.	Control n=50 eyes Subjects that wore the Control lens in either the first or second period of the study.
Area Under Contrast Sensitivity Function Curve Right Eye	1.254 log contrast sensitivity*cpd Standard Deviation 0.1746	1.273 log contrast sensitivity*cpd Standard Deviation 0.1584
Area Under Contrast Sensitivity Function Curve Both Eyes	1.524 log contrast sensitivity*cpd Standard Deviation 0.1092	1.535 log contrast sensitivity*cpd Standard Deviation 0.1022

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

Johnson & Johnson Vision Care

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60