Trial Outcomes & Findings for Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses (NCT NCT04954833)

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. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

10 minutes post lens insertion

Results posted on

2025-04-27

Participant Flow

A total of 60 subjects were enrolled in this study. Of those enrolled, 57 subjects were dispensed both study lenses and completed all study visits.

Participant milestones

Participant milestones
Measure	Test (EMO-200) \Control (EMO-118) Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period	Control (EMO-118) \Test (EMO-200) 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	28	29
Period 1 COMPLETED	28	29
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	28	29
Period 2 COMPLETED	28	29
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=57 Participants All subjects dispensed a study lens
Age, Continuous	10.6 Years STANDARD_DEVIATION 1.32 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	54 Participants n=5 Participants
Region of Enrollment United States	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes post lens insertion

Population: Subjects that completed all study visits without a major protocol deviation.

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. A logMAR visual performance score of 0.00 is equivalent to Snellen visual acuity of 20/20.

Outcome measures

Outcome measures
Measure	Test (EMO-200) n=114 Eyes Subjects that wore the Test lens in either the first or second period of the study.	Control (EMO-118) n=114 Eyes Subjects that wore the Control lens in either the first or second period of the study.
Monocular Distance Visual Acuity (logMAR)	-0.00 logMAR Standard Deviation 0.144	-0.00 logMAR Standard Deviation 0.140

SECONDARY outcome

Timeframe: 10 minutes post lens insertion

Population: All subjects that were fitted at least one study lens

Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion

Outcome measures

Outcome measures
Measure	Test (EMO-200) n=114 Eyes Subjects that wore the Test lens in either the first or second period of the study.	Control (EMO-118) n=114 Eyes Subjects that wore the Control lens in either the first or second period of the study.
Percentage of Subjects' Eyes With Acceptable Lens Fit	100 Percentage of acceptable lens fit	100 Percentage of acceptable lens fit

Adverse Events

Test (EMO-200)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (EMO-118)

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

Xu Cheng

Johnson & Johnson Vision Care, Inc. (JJVC)

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