Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses 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 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90012
      • Alcon Investigator 8135
    • Oakland, California, United States, 94607
      • Alcon Investigator 8062
    • San Francisco, California, United States, 94127
      • Alcon Investigator 8106
  • Florida
    • Longwood, Florida, United States, 32779
      • Alcon Investigator 6356
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
    • West Palm Beach, Florida, United States, 33405
      • Alcon Investigator 6654
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigator 6567
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Alcon Investigator 5582
  • Michigan
    • Sterling Heights, Michigan, United States, 48312
      • Alcon Investigator 8097
  • Minnesota
    • Willmar, Minnesota, United States, 56201
      • Alcon Investigator 7980
  • New York
    • New York, New York, United States, 10036
      • Alcon Investigator 8130
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Alcon Investigator 6401
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigator 6353
  • Texas
    • Austin, Texas, United States, 78731
      • Alcon Investigator 8175

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

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;
• Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
• 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: TOTAL30, then Biofinity; Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily 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: TOTAL30; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity; CooperVision® Biofinity®
Other: Biofinity, then TOTAL30; Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily 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: TOTAL30; 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 Distance VA (logMAR) With Study Lenses	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 30, each study product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): November 20, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CLY935-C019

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