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The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serafilcon A contact lenses
Senofilcon A contact lenses
CLEAR CARE
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-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.

Sites / Locations

  • Kurata Eyecare Center
  • Dr. Elsa Pao, OD
  • Pacific Rims Optometry
  • Omega Vision Center P.A.
  • Kindred Optics at Maitland Vision
  • Vision Health Institute
  • Tallahassee Eye Center
  • Heart of America Eye Care
  • The Eye Doctors Inc
  • Complete Eye Care of Medina
  • SUNY College of Optometry Clinical Vision Research Center
  • ProCare Vision Centers, Inc.
  • West Bay Eye Associates
  • Optometry Group, PLLC
  • Total Eye Care PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LID022821/AOHP

AOHP/LID022821

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Distance VA with study lenses at Week 1
Visual acuity (VA) at distance will be assessed with study lenses in place and measured in logarithm minimum angle of resolution (logMAR). VA will be collected for each eye individually.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2023
Last Updated
June 20, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05766787
Brief Title
The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Official Title
The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID022821/AOHP
Arm Type
Other
Arm Description
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.
Arm Title
AOHP/LID022821
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Serafilcon A contact lenses
Other Intervention Name(s)
LID022821
Intervention Description
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE OASYS® with HYDRACLEAR® PLUS Technology, AOHP
Intervention Description
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Other Intervention Name(s)
CLEAR CARE® Cleaning and Disinfecting Solution
Intervention Description
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
Distance VA with study lenses at Week 1
Description
Visual acuity (VA) at distance will be assessed with study lenses in place and measured in logarithm minimum angle of resolution (logMAR). VA will be collected for each eye individually.
Time Frame
Week 1, each study lens type

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead Alcon Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Kurata Eyecare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Dr. Elsa Pao, OD
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Pacific Rims Optometry
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Facility Name
Omega Vision Center P.A.
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Kindred Optics at Maitland Vision
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Eye Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Heart of America Eye Care
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
The Eye Doctors Inc
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
SUNY College of Optometry Clinical Vision Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Optometry Group, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

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