Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Study Overview

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

Detailed Description

In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Drs. Giedd, PA
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Wesley Optometric Consulting
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
• Habitual wear of AOHP contact lenses.
• Habitual wear of any daily disposable 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID022821, then AOHP; Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.	Device: CLEAR CARE; Hydrogen peroxide based contact lens cleaning and disinfecting solution; Other Names: CLEAR CARE® Cleaning and Disinfecting Solution; Device: Serafilcon A contact lenses; Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection; Other Names: LID022821; Device: Senofilcon A contact lenses; Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection; Other Names: AOHP; ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS
Other: AOHP, then LID022821; Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.	Device: CLEAR CARE; Hydrogen peroxide based contact lens cleaning and disinfecting solution; Other Names: CLEAR CARE® Cleaning and Disinfecting Solution; Device: Serafilcon A contact lenses; Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection; Other Names: LID022821; Device: Senofilcon A contact lenses; Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection; Other Names: AOHP; ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity With Study Lenses at Week 1 Follow-Up	Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.	Week 1, each wear period. A wear period was approximately 14 days.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLL949-E005

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