Last reviewed · How we verify

NCT04954833

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

Completed Results posted Last updated 27 April 2025
What this trial tests

trial testing EMO-200 in Visual Acuity in 60 participants. Completed in 16 August 2021.

Timeline
14 June 2021
Primary endpoint
16 August 2021
16 August 2021

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment60
Start date14 June 2021
Primary completion16 August 2021
Estimated completion16 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 7 to 12, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Monocular Distance Visual Acuity (logMAR) Primary · 10 minutes post lens insertion

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.

GroupValue95% CI
Test (EMO-200)-0.00± 0.144
Control (EMO-118)-0.00± 0.140
Percentage of Subjects' Eyes With Acceptable Lens Fit Secondary · 10 minutes post lens insertion

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

GroupValue95% CI
Test (EMO-200)100
Control (EMO-118)100

Sponsor's own description

This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing study to compare visual acuity and lens fit performance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Visual Acuity

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04954833.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing