Wear Experience With Daily Toric Contact Lenses Over a Long Day

Not Applicable

Completed

• Conditions: Contact Lens; Astigmatism of Both Eyes

• Registration Number: NCT04844281
• Lead Sponsor: Ohio State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-14
• Study Start: 2021-05-11
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Results First Submitted: 2023-09-27
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Results First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

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

Inclusion Criteria

• Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
• Distance visual acuity of 20/25 or better with current lenses.
• Recent eye exam in the last year.
• 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.
• Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
• Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Exclusion Criteria

• Current ocular inflammation or infection as assessed by the study investigator.
• Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)	Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.	1 describes poor experience, and 10 describes excellent experience.
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)	Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days	1 describes poor experience, and 10 describes excellent experience.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States