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

NCT05102383 | Completed Results FDA Device

• 1 other identifier: 2021H0305
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.

Conditions

Contact Lens

Outcome Measures

Primary Outcomes (1)

• Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism

  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")

  3 weeks

Study Arms (1)

All participants

EXPERIMENTAL

All participants have habitual Comfilcon A Toric lenses optimized for wear over 2 weeks. Then all participants are fit with the Verofilcon A study daily disposable lenses with water surface treatment for astigmatism.

Device: Comfilcon A Toric contact lenses; Device: Verofilcon A for Astigmatism Daily Disposable contact lenses

Interventions

Comfilcon A Toric contact lenses DEVICE

Monthly replacement contact lenses

All participants

Verofilcon A for Astigmatism Daily Disposable contact lenses DEVICE

Daily disposable contact lenses

All participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be a current wearer of Comfilcon A contact lenses
• Distance visual acuity of 20/25 or better with current contact lenses
• Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
• Ability to give informed consent
• Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits.
• Either gender.
• Any racial or ethnic origin.

You may not qualify if:

• No current ocular inflammation or infection.
• Not currently pregnant or lactating

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Results Point of Contact

• Title: Jennifer Fogt, OD MS
• Organization: The Ohio State University College of Optometry

OPTEyeStudies@osu.edu

16142928858

Study Officials

• Jennifer Fogt, OD MS

  The Ohio State University College of Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Optometry

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 1, 2021
• Study Start: November 15, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: November 25, 2025
• Results First Posted: December 6, 2023

Record last verified: 2025-11

Locations

US (1)