Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Study Overview

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

Detailed Description

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94607
      • Dr. Elsa Pao, OD
    • San Francisco, California, United States, 94127
      • Pacific Rims Optometry
  • Florida
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • North Spartanburg Eye Center
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research, LLC
  • Texas
    • Plano, Texas, United States, 75093
      • Dr Christina R Chang & Associates, OD, PA
    • San Antonio, Texas, United States, 78213
      • Dawn M. Rakich, OD

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:

• Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
• Manifest cylinder less than or equal to 0.75 diopter in each eye.
• Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Monovision or multifocal lens wearer.
• Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
• Routinely sleeps in habitual contact lenses.
• 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 AOHP; Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution; Device: Lehfilcon A contact lenses; Commercially available, silicone hydrogel, spherical contact lenses used as indicated; Other Names: LID018869; Device: Senofilcon A contact lenses; Commercially available, silicone hydrogel, spherical contact lenses used as indicated; Other Names: AOHP
Other: AOHP, then LID018869; Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution; Device: Lehfilcon A contact lenses; Commercially available, silicone hydrogel, spherical contact lenses used as indicated; Other Names: LID018869; Device: Senofilcon A contact lenses; Commercially available, silicone hydrogel, spherical contact lenses used as indicated; Other Names: AOHP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30	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.	Day 30, each study lens type

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-C022

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