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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: CLEAR CARE; Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90012
      • Alcon Investigative Site
    • Novato, California, United States, 94945
      • Alcon Investigative Site
    • Oakland, California, United States, 94513
      • Alcon Investigative Site
    • Oakland, California, United States, 94607
      • Alcon Investigative Site
    • San Francisco, California, United States, 94122
      • Alcon Investigative Site
  • Florida
    • Orlando, Florida, United States, 32803
      • Alcon Investigative Site
    • West Palm Beach, Florida, United States, 33405
      • Alcon Investigative Site
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Alcon Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40221
      • Alcon Investigative Site
  • New York
    • New York, New York, United States, 10036
      • Alcon Investigative Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Alcon Investigative Site
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Alcon Investigative Site
  • Texas
    • Plano, Texas, United States, 75093
      • Alcon Investigative Site
    • Wichita Falls, Texas, United States, 76308
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LID018869; Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution; Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869
Active Comparator: Biofinity; Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity; CooperVision® BIOFINITY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lens; Vision Correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-C012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No