The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Refractive Ametropia Clinical Trial

Official title:

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05766787
• Other study ID #: CLL949-C024
• Status: Completed
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: June 2, 2023

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Description:

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

• Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
• Habitual wear of AOHP contact lenses.
• Habitual wear of any daily disposable contact lenses.
• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• Serafilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
• Senofilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
• CLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	The Eye Doctors Inc	Eden Prairie	Minnesota
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Omega Vision Center P.A.	Longwood	Florida
United States	Kurata Eyecare Center	Los Angeles	California
United States	Kindred Optics at Maitland Vision	Maitland	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Total Eye Care PA	Memphis	Tennessee
United States	SUNY College of Optometry Clinical Vision Research Center	New York	New York
United States	Dr. Elsa Pao, OD	Oakland	California
United States	Vision Health Institute	Orlando	Florida
United States	Pacific Rims Optometry	San Francisco	California
United States	Heart of America Eye Care	Shawnee Mission	Kansas
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	West Bay Eye Associates	Warwick	Rhode Island

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 VA With Study Lenses at Week 1	Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.	Week 1 of each lens product worn during the corresponding crossover period