The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

NCT ID: NCT05766787

Last Updated: 2024-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2023-06-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Refractive Ametropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

Serafilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Senofilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

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.

Group Type OTHER

Serafilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Senofilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Interventions

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Serafilcon A contact lenses

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Intervention Type DEVICE

Senofilcon A contact lenses

Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID022821 ACUVUE OASYS® with HYDRACLEAR® PLUS Technology AOHP CLEAR CARE® Cleaning and Disinfecting Solution

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead Alcon Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Kurata Eyecare Center

Los Angeles, California, United States

Site Status

Dr. Elsa Pao, OD

Oakland, California, United States

Site Status

Pacific Rims Optometry

San Francisco, California, United States

Site Status

Omega Vision Center P.A.

Longwood, Florida, United States

Site Status

Kindred Optics at Maitland Vision

Maitland, Florida, United States

Site Status

Vision Health Institute

Orlando, Florida, United States

Site Status

Tallahassee Eye Center

Tallahassee, Florida, United States

Site Status

Heart of America Eye Care

Shawnee Mission, Kansas, United States

Site Status

The Eye Doctors Inc

Eden Prairie, Minnesota, United States

Site Status

Complete Eye Care of Medina

Medina, Minnesota, United States

Site Status

SUNY College of Optometry Clinical Vision Research Center

New York, New York, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

West Bay Eye Associates

Warwick, Rhode Island, United States

Site Status

Optometry Group, PLLC

Memphis, Tennessee, United States

Site Status

Total Eye Care PA

Memphis, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLL949-C024

Identifier Type: -

Identifier Source: org_study_id

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