Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2010-10-31
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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Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.
Acuvue Advance Plus prePQ
silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
Acuvue Advance Plus postPQ
silicone hydrogel contact lens manufactured after equipment process qualification activities.
Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.
Acuvue Advance Plus prePQ
silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
Acuvue Advance Plus postPQ
silicone hydrogel contact lens manufactured after equipment process qualification activities.
Interventions
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Acuvue Advance Plus prePQ
silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
Acuvue Advance Plus postPQ
silicone hydrogel contact lens manufactured after equipment process qualification activities.
Eligibility Criteria
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Inclusion Criteria
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
18 Years
39 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Powell, Ohio, United States
Warwick, Rhode Island, United States
Salem, Virginia, United States
Countries
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Other Identifiers
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CR-1636BI
Identifier Type: -
Identifier Source: org_study_id
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