Trial Outcomes & Findings for Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens (NCT NCT05102383)

NCT ID: NCT05102383

Last Updated: 2025-11-25

Results Overview

Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort")

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2025-11-25

Participant Flow

Participant milestones

Measure	Habitual Lens Optimization Followed by Refitting With Study Lenses All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens

Baseline characteristics by cohort

Measure	Habitual Lens Optimization Followed by Refitting With Study Lenses n=30 Participants All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment.
Age, Categorical <=18 years	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants
Age, Continuous	27.2 years STANDARD_DEVIATION 4.0 • n=45 Participants
Sex: Female, Male Female	20 Participants n=45 Participants
Sex: Female, Male Male	10 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	7 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	4 Participants n=45 Participants
Race (NIH/OMB) White	19 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Region of Enrollment United States	30 participants n=45 Participants

PRIMARY outcome

Timeframe: 3 weeks

Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort")

Outcome measures

Measure	Habitual Lens Optimization Followed by Refitting With Study Lenses n=30 Participants All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment.
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism	91 units on a scale Interval 80.0 to 100.0

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=30 participants at risk All participants are re-fit to optimize fit and vision with their habitual Comfilcon A lenses before being fit with the study lenses. These optimized lenses were worn for 2 weeks before returning to be refit with the study daily disposable lenses.
Eye disorders Hordeolum/Stye	3.3% 1/30 • Number of events 30 • 1 month

Additional Information

Jennifer Fogt, OD MS

The Ohio State University College of Optometry

Phone: 16142928858

Email: OPTEyeStudies@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place