Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
NCT ID: NCT04207749
Last Updated: 2022-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
249 participants
INTERVENTIONAL
2020-01-22
2020-12-17
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 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
LID015385 contact lenses
Investigational soft contact lenses
CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution
Biofinity
Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
Comfilcon A contact lenses
Commercially available soft contact lenses
CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution
Interventions
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LID015385 contact lenses
Investigational soft contact lenses
Comfilcon A contact lenses
Commercially available soft 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 and wear the assigned study lenses as required per protocol.
* Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Best spectacle corrected visual acuity 20/20 or better in each eye.
Exclusion Criteria
* Monovision contact lens wear.
* Any habitual wear of Biofinity lenses.
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 Investigator 8103
Glendale, Arizona, United States
Alcon Investigator 8101
Brentwood, California, United States
Alcon Investigator 8102
Irvine, California, United States
Alcon Investigator 8135
Los Angeles, California, United States
Alcon Investigator 8108
Novato, California, United States
Alcon Investigator 8062
Oakland, California, United States
Alcon Investigator 8109
San Francisco, California, United States
Alcon Investigator 6565
Maitland, Florida, United States
Alcon Investigator 6355
Orlando, Florida, United States
Alcon Investigator 8115
Norcross, Georgia, United States
Alcon Investigator 6567
Pittsburg, Kansas, United States
Alcon Investigator 8063
Brighton, Massachusetts, United States
Alcon Investigator 8100
New York, New York, United States
Alcon Investigator 4817
Cleveland, Ohio, United States
Alcon Investigator 6313
Powell, Ohio, United States
Alcon Investigator 6401
Warwick, Rhode Island, United States
Alcon Investigator 6353
Memphis, Tennessee, United States
Alcon Investigator 8114
Plano, 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-C018
Identifier Type: -
Identifier Source: org_study_id
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