Trial Outcomes & Findings for Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop (NCT NCT06131476)

Results Overview

High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

3 minutes post instillation

Results posted on

2024-06-26

Participant Flow

A total of 32 subjects were enrolled from two clinical sites in this study. Of those enrolled, a total of 31 (96.9%) subjects were randomly assigned among 2 unique eye drop sequences, study eye drops administered in both eyes for all subjects and were included in Safety Population; while, one (3.1%) subject was a screen failure and/or not assigned. Of the total assigned subjects, all 31 (96.9%) subjects completed the study.

Participant milestones

Participant milestones
Measure	Investigational Lipid Drop\Blink Tears Subjects randomized to this sequence received Investigational Lipid Drop during the first period and then received Blink Tears during the second period	Blink Tears\Investigational Lipid Drop Subjects randomized to this sequence received Blink Tears during the first period and then received Investigational Lipid Drop during the second period
Period 1 STARTED	15	16
Period 1 COMPLETED	15	16
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	15	16
Period 2 COMPLETED	15	16
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 a Lipid- Based Lubricating Eye Drop

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=31 Participants All subjects who instilled at least one eye drop.
Age, Continuous	34.9 Years STANDARD_DEVIATION 8.62 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes post instillation

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

High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.

Outcome measures

Outcome measures
Measure	Investigational Lipid Drop n=62 Eyes Subjects who instilled the Investigational Lipid Drop in the first or second period of the study.	Blink Tears n=62 Eyes Subjects who instilled the Blink Tears in the first or second period of the study.
Visual Acuity (logMAR) at 3 Minutes Post Instillation	0.09 LogMAR Standard Deviation 0.082	0.08 LogMAR Standard Deviation 0.088

PRIMARY outcome

Timeframe: 10 minutes post instillation

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

High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.

Outcome measures

Outcome measures
Measure	Investigational Lipid Drop n=62 Eyes Subjects who instilled the Investigational Lipid Drop in the first or second period of the study.	Blink Tears n=62 Eyes Subjects who instilled the Blink Tears in the first or second period of the study.
Visual Acuity (logMAR) at 10 Minutes Post Instillation	0.09 LogMAR Standard Deviation 0.095	0.09 LogMAR Standard Deviation 0.087

Adverse Events

Investigational Lipid Drop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blink Tears

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

Principal Research Optometrist, Clinical Sciences

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