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

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution

Detailed Description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

• Study Type: Interventional
• Enrollment (Actual): 36
• 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
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • 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

Inclusion Criteria:

• Sign Informed Consent document.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition or disease or use of medication that contraindicates contact lens wear.
• Eye surgery, irregular cornea, eye injury as specified in the protocol.
• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
• Habitually wears Biofinity contact lenses.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID017569, then Biofinity; Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID017569; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity®; Device: Multi-purpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®
Other: Biofinity, then LID017569; Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID017569; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity®; Device: Multi-purpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance VA (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). 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 30 after a minimum of 6 hours of wear, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-C007

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