Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
NCT ID: NCT04085328
Last Updated: 2023-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
675 participants
INTERVENTIONAL
2019-10-11
2021-03-26
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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LID015385
LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.
LID015385 soft contact lenses
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Biofinity
Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.
Comfilcon A soft contact lenses
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Interventions
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LID015385 soft contact lenses
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Comfilcon A soft contact lenses
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to attend all scheduled study visits as required per protocol.
* Willing and able to wear assigned study lenses as required per protocol.
* Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
Exclusion Criteria
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of eye surgery, including refractive surgery.
* Currently pregnant or breast-feeding.
* Monovision contact lens wearers.
* Daily disposable 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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Alcon Study Director
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Family EyeCare Center
Campbell, California, United States
Winston Eye Care
Fullerton, California, United States
Kurata Eye Care Center
Los Angeles, California, United States
East West Eye Institute
Los Angeles, California, United States
Dr.Elsa Pao, O.D
Oakland, California, United States
Gordon Schanzlin New Vision Institute
San Diego, California, United States
Complete Family Vision Care
San Diego, California, United States
Westview Optometry
San Diego, California, United States
OMEGA Vision Center PA, DBA Sabal Eye Care
Longwood, Florida, United States
Kindred Optics at Maitland Vision Center
Maitland, Florida, United States
Mid Florida Eye Center, PA
Mt. Dora, Florida, United States
Eola Eyes
Orlando, Florida, United States
Vision Health Institute
Orlando, Florida, United States
Visual Performance Center Research & Development
Pensacola, Florida, United States
Golden Vision
Sarasota, Florida, United States
Advanced Eyecare Specialists
West Palm Beach, Florida, United States
VisionPoint Eye Center
Bloomington, Illinois, United States
Franklin Park Eye Center, PC
Franklin Park, Illinois, United States
Kannarr Eye Care, LLC
Pittsburg, Kansas, United States
Optimum Vision Care
Brighton, Massachusetts, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Dr. Schwartz Optometrist and Associates
Sterling Heights, Michigan, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Fischer Laser Eye Center, LLC
Willmar, Minnesota, United States
Tekwnai Vision Center, Inc
St Louis, Missouri, United States
Alterman, Modi & Wolter
Poughkeepsie, New York, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Asheville Eye Associates, PLLC
Asheville, North Carolina, United States
ProCare Vision Centers, Inc.
Granville, Ohio, United States
Midwest Vision Care
Piqua, Ohio, United States
EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
Powell, Ohio, United States
Wyomissing Optometric Center
Wyomissing, Pennsylvania, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
North Spartanburg Eye Center
Boiling Springs, South Carolina, United States
Primary Eyecare Group, PC
Brentwood, Tennessee, United States
Optometry Group, PLLC
Memphis, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Advancing Vision Research, LLC
Smyrna, Tennessee, United States
Beaumont Family Eye Care
Beaumont, Texas, United States
Vision One Eyecare
Katy, Texas, United States
Dawn M Rakich, OD
San Antonio, Texas, United States
Clarke EyeCare Center
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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CLL949-C010
Identifier Type: -
Identifier Source: org_study_id
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