Wear Experience With Daily Toric Contact Lenses Over a Long Day

Contact Lens Clinical Trial

Official title:

Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844281
• Other study ID #: 2020H0559
• Status: Completed
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: August 24, 2021

Study information

• Verified date: November 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism of Both Eyes
• Contact Lens

Intervention

Device:
• Precision1® Daily Disposable Toric Contact Lens
Soft, toric contact lens used to correct distance vision and astigmatism.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 describes poor experience, and 10 describes excellent experience.	Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
Primary	Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)	1 describes poor experience, and 10 describes excellent experience.	Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days