Clinical Performance of Two Daily Disposable Soft Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Performance of Two Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138783
• Other study ID #: CLE383-P006
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: March 7, 2022

Study information

• Verified date: March 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Description:

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

• Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.

• Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.

• Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.

• Monovision and multifocal lens wear.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
• Nesofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	Franklin Park Eye Center PC	Franklin Park	Illinois
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Kindred Optics at Maitland Vision	Maitland	Florida
United States	Complete Eye Care Of Medina	Medina	Minnesota
United States	Heart of America Eye Care	Shawnee Mission	Kansas
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	Stine Eye Center	Weston	Wisconsin
United States	Clarke EyeCare Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Squares Mean Distance Visual Acuity (VA) With Study Lenses	Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.	Day 8 (-0/+3 days), each study lens type