Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
NCT ID: NCT04980456
Last Updated: 2023-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
257 participants
INTERVENTIONAL
2021-08-05
2021-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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TOTAL30, then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution
Biofinity, then TOTAL30
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
CLEAR CARE
Hydrogen peroxide-based 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 cleaning and disinfecting solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to attend all scheduled study visits as required by the protocol;
* Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion Criteria
* Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Vision Care
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Alcon Investigator 8135
Los Angeles, California, United States
Alcon Investigator 8062
Oakland, California, United States
Alcon Investigator 8106
San Francisco, California, United States
Alcon Investigator 6356
Longwood, Florida, United States
Alcon Investigator 6565
Maitland, Florida, United States
Alcon Investigator 6654
West Palm Beach, Florida, United States
Alcon Investigator 6567
Pittsburg, Kansas, United States
Alcon Investigator 5582
Louisville, Kentucky, United States
Alcon Investigator 8097
Sterling Heights, Michigan, United States
Alcon Investigator 7980
Willmar, Minnesota, United States
Alcon Investigator 8130
New York, New York, United States
Alcon Investigator 6401
Warwick, Rhode Island, United States
Alcon Investigator 6353
Memphis, Tennessee, United States
Alcon Investigator 8175
Austin, 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-C019
Identifier Type: -
Identifier Source: org_study_id
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