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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04422990
Other study ID # CLY935-C012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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