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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05766787
Other study ID # CLL949-C024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04013789 - Comparison of Two Daily Disposable Lenses N/A
Completed NCT05565937 - A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution N/A