Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Refractive Errors Clinical Trial

Official title:

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422990
• Other study ID #: CLY935-C012
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: March 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Description:

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 18, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;

• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;

• Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Habitually wearing Biofinity lenses;

• Monovision or multifocal contact lens wearers;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
• Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
• CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Boiling Springs	South Carolina
United States	Alcon Investigative Site	Cleveland	Ohio
United States	Alcon Investigative Site	Downers Grove	Illinois
United States	Alcon Investigative Site	Los Angeles	California
United States	Alcon Investigative Site	Louisville	Kentucky
United States	Alcon Investigative Site	New York	New York
United States	Alcon Investigative Site	Novato	California
United States	Alcon Investigative Site	Oakland	California
United States	Alcon Investigative Site	Oakland	California
United States	Alcon Investigative Site	Orlando	Florida
United States	Alcon Investigative Site	Plano	Texas
United States	Alcon Investigative Site	San Francisco	California
United States	Alcon Investigative Site	West Palm Beach	Florida
United States	Alcon Investigative Site	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 Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up	Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.	Week 1 Follow-Up
Secondary	Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up	Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.	Week 1 Follow-Up