Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism Bilateral
• Interventions: Device: Daily disposable toric soft contact lens; Device: Monthly replacement toric daily wear soft contact lens

• Registration Number: NCT05580575
• Lead Sponsor: Ohio State University

Brief Summary

Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-14
• Study Start: 2022-11-01
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2024-04
• Results First Submitted: 2024-04-01
• Results First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Results First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Subjects must be current soft lens wearers in both eyes.
• Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
• 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. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
• Either gender
• Any racial or ethnic origin

Exclusion Criteria

• Participants cannot be pregnant or lactating.
• Participants cannot be current wearers of the study lenses
• No current ocular inflammation or infection as assessed by the study investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reusable lens worn first, daily disposable lens worn second	Daily disposable toric soft contact lens	Subject will wear each contact lenses for 30 days during the day only.
Daily disposable lens worn first, reusable lens worn second	Daily disposable toric soft contact lens	Subject will wear each contact lenses for 30 days during the day only.
Daily disposable lens worn first, reusable lens worn second	Monthly replacement toric daily wear soft contact lens	Subject will wear each contact lenses for 30 days during the day only.
Reusable lens worn first, daily disposable lens worn second	Monthly replacement toric daily wear soft contact lens	Subject will wear each contact lenses for 30 days during the day only.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Survey of Overall Comfort	1 month	Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"

Trial Locations

Locations (3)

ProCare Vision Center; 🇺🇸 Granville, Ohio, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

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