Back to resultsClinical 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
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Myopia
Eligibility Criteria
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.
Sites / Locations
- Drs. Giedd, PA
- Wesley Optometric Consulting
- ProCare Vision Center
- West Bay Eye Associates
- Optometry Group, PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID022821, then AOHP
AOHP, then LID022821
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05431478
Brief Title
Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Official Title
Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (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
Product Manufactured in and Exported from the U.S.
No
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 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).
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
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID022821, then AOHP
Arm Type
Other
Arm Description
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.
Arm Title
AOHP, then LID022821
Arm Type
Other
Arm Description
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.
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 daily cleaning and disinfection
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS, AOHP
Intervention Description
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily 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
Visual Acuity With Study Lenses at Week 1 Follow-Up
Description
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.
Time Frame
Week 1, each wear period. A wear period was approximately 14 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, CDMA Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Drs. Giedd, PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Wesley Optometric Consulting
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
ProCare Vision Center
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
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