Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
NCT ID: NCT01966770
Last Updated: 2020-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-10-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Interventions
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Pair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Pair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Pair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Pair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Pair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Pair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Eligibility Criteria
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Inclusion Criteria
* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (diopter) in each eye
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule
Exclusion Criteria
* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of -1.00 to -6.00D
* Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
* Has best corrected spectacle distance vision worse than 20/25 in either eye
* Has any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is presbyopic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related conical or research study
18 Years
40 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Meng Lin, OD PhD FAAO
Role: PRINCIPAL_INVESTIGATOR
CRC-UC Berkeley
Locations
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University of California, Berkeley Clinical Research Center (UCB-CRC)
Berkeley, California, United States
Countries
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Other Identifiers
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EX-MKTG-44
Identifier Type: -
Identifier Source: org_study_id
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