The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
1 other identifier
interventional
190
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2023
CompletedResults Posted
Study results publicly available
June 13, 2024
CompletedJune 13, 2024
May 1, 2024
2 months
March 1, 2023
May 17, 2024
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Least Squares Mean Distance VA With Study Lenses at Week 1
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
Study Arms (2)
LID022821, then AOHP
OTHERSerafilcon 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.
AOHP, then LID022821
OTHERSenofilcon 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.
Interventions
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Hydrogen peroxide based contact lens cleaning and disinfecting solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (15)
Kurata Eyecare Center
Los Angeles, California, 90013, United States
Dr. Elsa Pao, OD
Oakland, California, 94607, United States
Pacific Rims Optometry
San Francisco, California, 94127, United States
Omega Vision Center P.A.
Longwood, Florida, 32779, United States
Kindred Optics at Maitland Vision
Maitland, Florida, 32751, United States
Vision Health Institute
Orlando, Florida, 32803, United States
Tallahassee Eye Center
Tallahassee, Florida, 32308, United States
Heart of America Eye Care
Shawnee Mission, Kansas, 66204, United States
The Eye Doctors Inc
Eden Prairie, Minnesota, 55344, United States
Complete Eye Care of Medina
Medina, Minnesota, 55340, United States
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10036, United States
ProCare Vision Centers, Inc.
Granville, Ohio, 43023, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Optometry Group, PLLC
Memphis, Tennessee, 38111, United States
Total Eye Care PA
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Lead, Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead Alcon Vision Care
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 13, 2023
Study Start
March 29, 2023
Primary Completion
June 2, 2023
Study Completion
June 2, 2023
Last Updated
June 13, 2024
Results First Posted
June 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share