Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
NCT ID: NCT01484028
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
275 participants
INTERVENTIONAL
2011-11-30
2012-02-29
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
NONE
Study Groups
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EALE/1DM
etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
etafilcon A control lens (1DM)
A marketed daily disposable contact lens
etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
1DM/EALE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
etafilcon A control lens (1DM)
A marketed daily disposable contact lens
etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
EADE/1DM
etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
etafilcon A control lens (1DM)
A marketed daily disposable contact lens
etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens
1DM/EADE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
etafilcon A control lens (1DM)
A marketed daily disposable contact lens
etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens
Interventions
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etafilcon A control lens (1DM)
A marketed daily disposable contact lens
etafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
etafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
* Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
* Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
* Any cylinder power must be: \<=0.75D
* Visual acuity must be best correctable to 20/25 or better for each eye
* Must have normal eyes (no ocular medications or ocular infection of any type)
* Must read and sign the Statement of Informed Consent
* Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria
* Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
* Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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
* Any color deficiencies (colorblindness) - to the best of the subject's knowledge
* 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.
* Subject presents with one dark iris color and one light iris color.
* Subject has heterochromia iridis (a difference in color between parts of one iris).
* The subject must not be an employee or family member of the clinical study site.
18 Years
34 Years
FEMALE
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Optometry
Mission Viejo, California, United States
James R Dugue, Optometrist
Mission Viejo, California, United States
Advance Eye Care
Pismo Beach, California, United States
Golden Vision
Sarasota, Florida, United States
Eye Associates of Winter Park
Winter Park, Florida, United States
Eye Care Associates
Bloomington, Illinois, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Vision Care
East Lansing, Michigan, United States
Spectrum Eye Care
Jamestown, New York, United States
Sacco Eye Group
Vestal, New York, United States
The Eye Care Group
Grants Pass, Oregon, United States
Dr. David W Ferris and Associates
Warwick, Rhode Island, United States
Wishnow Sugar Group
Katy, Texas, United States
Isthmus Eye Care
Middleton, Wisconsin, United States
Snowy Range Cision Center
Laramie, Wyoming, United States
Countries
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Other Identifiers
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CR-005094
Identifier Type: -
Identifier Source: org_study_id
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