Vistakon Investigational Contact Lenses Worn for Daily Wear
NCT ID: NCT00717249
Last Updated: 2016-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
529 participants
INTERVENTIONAL
2007-08-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test Lens
galyfilcon A contact lens with a silver additive
galyfilcon A with a silver additive
Investigational daily wear contact lens
Control Lens
galyfilcon A control contact lens
galyifilcon A control lens
Marketed daily wear contact lens
Interventions
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galyifilcon A control lens
Marketed daily wear contact lens
galyfilcon A with a silver additive
Investigational daily wear contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Both males and females may be enrolled.
3. The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
4. The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.
Exclusion Criteria
2. Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
3. Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
4. The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
5. Moderate or above corneal distortion by keratometry.
6. Known allergy to silver, silver ions, or silver containing compounds.
7. Abnormal discoloration of the cornea and/or conjunctiva.
8. Routine exposure to silver, silver ions, or silver containing compounds.
9. The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)
10. Free of systemic and infectious diseases: hepatitis and tuberculosis.
11. Subjects must be HIV negative.
12. The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
13. The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
14. The subject must not have more than 1.00D of refractive astigmatism in either eye.
15. The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
16. The subject must not be monovision corrected.
17. The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
18. The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)
19. The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
20. The subject must not have had an eye injury within 8 weeks prior to study enrollment.
21. The subject must not have had previous eye surgery.
22. The subject must be successfully trial fitted with the study contact lenses.
18 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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Cole, Cole, and Krohn
Fresno, California, United States
Dr. James R. Dugue Family Optometrist
Mission Viejo, California, United States
Fukai and Associates
Louisville, Colorado, United States
Baymeadows Vision Center
Jacksonville, Florida, United States
Eyecare Associates
Bloomington, Illinois, United States
Advantage Eyecare Associates, LLC
Neodesha, Kansas, United States
InSight Eyecare
Warrensburg, Missouri, United States
Spectrum Eyecare
Jamestown, New York, United States
Drs. Quinn, Quinn and Associates
Athens, Ohio, United States
Dr. Michael H. Greenburg, Inc.
Chagrin Falls, Ohio, United States
Central Ohio Eyecare
Columbus, Ohio, United States
James W. Kershaw OD, Inc.
North Olmsted, Ohio, United States
West Hills Vision Center
Moon Township, Pennsylvania, United States
Nittany Eye Associates
State College, Pennsylvania, United States
Research Across America
Wyomissing, Pennsylvania, United States
Dr. David W. Ferris and Associates
Warwick, Rhode Island, United States
Premier Vision
Amarillo, Texas, United States
William J. Bogus OD
Salt Lake City, Utah, United States
The Eye Speciliasts, Ltd
Virginia Beach, Virginia, United States
Snowy Range Vision Center
Laramie, Wyoming, United States
Countries
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Other Identifiers
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CR-1513
Identifier Type: -
Identifier Source: org_study_id
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