Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Study Overview

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

Detailed Description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Alcon Investigative Site
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigative Site
    • Shawnee Mission, Kansas, United States, 66204
      • Alcon Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or prior Biofinity contact lens wearer in the past 3 months;
• Monovision contact lens wearer;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID018869, then Biofinity; Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution; Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity; CooperVision® BIOFINITY®
Other: Biofinity, then LID018869; Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution; Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869; 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
Mean Distance Visual Acuity (logMAR) With Study Lenses	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.	Day 1, Day 30 after 6-8 hours of wear, each product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CLY935-C013

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