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

NCT ID: NCT05102383

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-04-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All participants

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.

Group Type: EXPERIMENTAL

Comfilcon A Toric contact lenses

Intervention Type: DEVICE

Monthly replacement contact lenses

Verofilcon A for Astigmatism Daily Disposable contact lenses

Intervention Type: DEVICE

Daily disposable contact lenses

Interventions

Comfilcon A Toric contact lenses

Monthly replacement contact lenses

Intervention Type: DEVICE

Verofilcon A for Astigmatism Daily Disposable contact lenses

Daily disposable contact lenses

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Fogt

Associate Professor of Clinical Optometry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Fogt, OD MS

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University College of Optometry

Locations

The Ohio State University College of Optometry

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2021H0305

Identifier Type: -

Identifier Source: org_study_id