Trial Outcomes & Findings for Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops (NCT NCT05814367)

Last Updated: 2025-04-27

Results Overview

Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity 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

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

10 Minutes Post Eye Drop Administration

Results posted on

2025-04-27

Participant Flow

A total of 46 subjects were enrolled in this study. Of those enrolled, 44 subjects were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. All 44 dispensed subjects completed the study. 1-2 drops of Test and Control eye drops were administered to both eyes for every subject. This is a single visit study with 90-minute washout between period 1 and 2.

Participant milestones

Participant milestones
Measure	Test\Control Subjects randomized to receive the Test Eye Drop in both eyes during the first period and the Control Eye Drop in both eyes during the second period	Control\Test Subjects randomized to receive the Control Eye Drop in both eyes during the first period and the Test Eye Drop in both eyes during the second period
Period 1 STARTED	22	22
Period 1 COMPLETED	22	22
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	22	22
Period 2 COMPLETED	22	22
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=44 Participants All subjects dispensed at least one study lens
Age, Continuous	33.7 years STANDARD_DEVIATION 8.19 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 Minutes Post Eye Drop Administration

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol.

Outcome measures

Outcome measures
Measure	Test n=88 Eyes Subjects that received Test (Investigational) eye drop during either period of the study.	Control n=88 Eyes Subjects that received the Control eye drop during either period of the study.
Monocular logMAR Visual Acuity	0.033 logMAR Standard Deviation 0.1131	0.038 logMAR Standard Deviation 0.1206

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

Nabin Joshi

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