Wear Experience With Daily Contact Lenses Over a Long Day

Contact Lens Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535310
• Other study ID #: 2020H0324
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: February 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 contact lens after 10, 12, 14, and 16 hours of lens wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 31, 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contact Lens

Intervention

Device:
• Precision1® Daily Disposable Contact Lens
Soft, spherical contact lens used to correct distance vision.

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	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 Overall Comfort as Assessed Using the Visual Analog Scale (VAS)	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.	Up to 14 days