Evaluation of Wear Experience With Daily Contact Lenses

Not Applicable

Completed

• Conditions: Contact Lens
• Interventions: Device: Precision1® Daily Disposable Contact Lens

• Registration Number: NCT05096156
• Lead Sponsor: Ohio State University

Brief Summary

To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-28
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-27
• Primary Completion: 2021-11-17
• Study Completion: 2021-12-17
• Results First Submitted: 2023-09-27
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Results First Posted: 2023-11-08
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

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

Inclusion Criteria

• Currently wear Biofinity® monthly replacement spherical 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 two study visits and wearing contact lenses on days between study visits.

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 are fit with the study daily disposable lenses	Precision1® Daily Disposable Contact Lens	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses.

Primary Outcome Measures

Name	Time	Method
Subjective Assessment of Precision1® Daily Disposable Contact Lens	2 weeks	Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)

Trial Locations

Locations (1)

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