Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
NCT ID: NCT04422990
Last Updated: 2022-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2020-10-01
2021-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LID018869
Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Biofinity
Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Interventions
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Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
* Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
Exclusion Criteria
* Habitually wearing Biofinity lenses;
* Monovision or multifocal contact lens wearers;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Trial Lead, CDMA Vision Care
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Alcon Investigative Site
Los Angeles, California, United States
Alcon Investigative Site
Novato, California, United States
Alcon Investigative Site
Oakland, California, United States
Alcon Investigative Site
Oakland, California, United States
Alcon Investigative Site
San Francisco, California, United States
Alcon Investigative Site
Orlando, Florida, United States
Alcon Investigative Site
West Palm Beach, Florida, United States
Alcon Investigative Site
Downers Grove, Illinois, United States
Alcon Investigative Site
Louisville, Kentucky, United States
Alcon Investigative Site
New York, New York, United States
Alcon Investigative Site
Cleveland, Ohio, United States
Alcon Investigative Site
Boiling Springs, South Carolina, United States
Alcon Investigative Site
Plano, Texas, United States
Alcon Investigative Site
Wichita Falls, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLY935-C012
Identifier Type: -
Identifier Source: org_study_id
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