The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

May 17, 2024 updated by: Alcon Research
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

Intervention / Treatment

Detailed Description

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90013
        • Kurata Eyecare Center
      • Oakland, California, United States, 94607
        • Dr. Elsa Pao, OD
      • San Francisco, California, United States, 94127
        • Pacific Rims Optometry
    • Florida
      • Longwood, Florida, United States, 32779
        • Omega Vision Center P.A.
      • Maitland, Florida, United States, 32751
        • Kindred Optics at Maitland Vision
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Eye Center
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Heart of America Eye Care
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55344
        • The Eye Doctors Inc
      • Medina, Minnesota, United States, 55340
        • Complete Eye Care of Medina
    • New York
      • New York, New York, United States, 10036
        • SUNY College of Optometry Clinical Vision Research Center
    • Ohio
      • Granville, Ohio, United States, 43023
        • Procare Vision Centers, Inc.
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • West Bay Eye Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care PA
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (BCVA) 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-specific inclusion criteria may apply.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LID022821, then AOHP
Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Device: Serafilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for 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 cleaning and disinfection
Other Names:
  • AOHP
  • ACUVUE OASYS® with HYDRACLEAR® PLUS Technology
Device: CLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution
Other: AOHP, then LID022821
Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Device: Serafilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for 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 cleaning and disinfection
Other Names:
  • AOHP
  • ACUVUE OASYS® with HYDRACLEAR® PLUS Technology
Device: CLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Least Squares Mean Distance VA With Study Lenses at Week 1
Time Frame: Week 1 of each lens product worn during the corresponding crossover period
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Week 1 of each lens product worn during the corresponding crossover period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Actual)

June 2, 2023

Study Completion (Actual)

June 2, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL949-C024

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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