Wear Experience With Daily Contact Lenses Over a Long Day

Not Applicable

Completed

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

• Registration Number: NCT04535310
• Lead Sponsor: Ohio State University

Brief Summary

This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-01
• Study Start: 2020-10-13
• Primary Completion: 2020-12-08
• Study Completion: 2021-03-31
• Results First Submitted: 2022-10-13
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Must be a current spherical contact lens wearer with longs days of lens wear.
• 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).
• Recent eye exam within the past year.
• Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
• Ability to give informed consent.
• Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria

• No current ocular inflammation or infection as assessed by the study investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daily Disposable Contact Lens	Precision1® Daily Disposable Contact Lens	All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.

Primary Outcome Measures

Name	Time	Method
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)	Up to 14 days	Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.

Trial Locations

Locations (1)

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