Trial Outcomes & Findings for 2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses (NCT NCT05126953)

Results Overview

Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Assessed at 2-hour post-baseline

Results posted on

2025-07-20

Participant Flow

This is a contralateral study. 30 subjects were enrolled and were dispensed lenses based on a randomization schedule.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. Each participant wore the test lens in one eye and the control lens in the fellow eye for 2 hours.
Overall Study STARTED	30 60
Overall Study Samfilcon A Lenses With EPG01 Packaging Solution	30 30
Overall Study B+L Ultra Lenses	30 30
Overall Study COMPLETED	30 60
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. n=60 Eyes Participants were implanted with both samfilcon A Lenses with EPG01 Packaging Solution and commercially available B+L Ultra lenses.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	40.7 Years STANDARD_DEVIATION 12.62 • n=30 Participants
Sex: Female, Male Female	12 Participants n=30 Participants
Sex: Female, Male Male	18 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Assessed at 2-hour post-baseline

Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.

Outcome measures

Outcome measures
Measure	Samfilcon A Lenses With EPG01 Packaging Solution n=30 Lenses Participants were implanted with samfilcon A Lenses with EPG01 Packaging Solution	Commercially Available B+L Ultra Lenses n=30 Lenses Participants were implanted with commercially available B+L Ultra lenses.
Normalized logMAR Visual Acuity INS visit	0.005 LogMAR units Standard Deviation 0.0577	0.003 LogMAR units Standard Deviation 0.0633
Normalized logMAR Visual Acuity FUP visit	-0.001 LogMAR units Standard Deviation 0.0663	0.008 LogMAR units Standard Deviation 0.0632

Adverse Events

Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses.

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

Schafer, Jill

Bausch + Lomb Incorporated

Phone: 0000000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place