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

Not Applicable

Completed

• Conditions: Contact Lens
• Interventions: Device: Comfilcon A Toric contact lenses; Device: Verofilcon A for Astigmatism Daily Disposable contact lenses

• Registration Number: NCT05102383
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-01
• Study Start: 2021-11-15
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Results First Submitted: 2023-09-27
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Results First Posted: 2023-12-06
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Comfilcon A Toric contact lenses	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.
All participants	Verofilcon A for Astigmatism Daily Disposable contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism	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")

Trial Locations

Locations (1)

The Ohio State University College of Optometry; 🇺🇸 Columbus, Ohio, United States