Wear Experience With Daily Toric Contact Lenses Over a Long Day

• Sponsor: Ohio State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04844281
• Collaborator: Alcon Research (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens; Astigmatism of Both Eyes	Device: Precision1® Daily Disposable Toric Contact Lens	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days
• Actual Study Start Date: May 11, 2021
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daily Disposable Toric Contact Lens All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.	Device: Precision1® Daily Disposable Toric Contact Lens; Soft, toric contact lens used to correct distance vision and astigmatism.

Outcome Measures

Primary Outcome Measures

1. Comfort and vision in contact lenses assessed using a 1 to 10 scale. [Up to 14 days]

   1 describes poor experience, and 10 describes excellent experience.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Fogt, Associate Professor of Clinical Optometry, Ohio State University
• ClinicalTrials.gov Identifier: NCT04844281
• Other Study ID Numbers: 2020H0559
• First Posted: Apr 14, 2021
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Jennifer Fogt, Associate Professor of Clinical Optometry, Ohio State University: Toric Contact Lens; Daily Contact Lens
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Oct 21, 2021