Evaluation of Wear Experience With a Daily Disposable Contact Lens

Not Applicable

Completed

• Conditions: Contact Lens
• Interventions: Device: Daily Disposable Contact Lens

• Registration Number: NCT04296877
• Lead Sponsor: Ohio State University

Brief Summary

To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Detailed Description

This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Study Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Study Start: 2020-03-10
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Results First Submitted: 2022-10-13
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Results First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Must be current Acuvue® Oasys® spherical contact lens wearers.
• 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 two study visits and wearing 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 study participants	Daily Disposable Contact Lens	All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for \~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.

Primary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey	2 weeks	Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.

Trial Locations

Locations (1)

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