Status:
COMPLETED
Vistakon Investigational Contact Lenses Worn for Daily Wear
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares the performance of an investigational contact lens to a currently marketed lens.
Eligibility Criteria
Inclusion
- The subject must be at least 18 years of age.
- Both males and females may be enrolled.
- The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
- The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.
Exclusion
- The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
- Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
- Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
- 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.
- Moderate or above corneal distortion by keratometry.
- Known allergy to silver, silver ions, or silver containing compounds.
- Abnormal discoloration of the cornea and/or conjunctiva.
- Routine exposure to silver, silver ions, or silver containing compounds.
- 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)
- Free of systemic and infectious diseases: hepatitis and tuberculosis.
- Subjects must be HIV negative.
- The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
- The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
- The subject must not have more than 1.00D of refractive astigmatism in either eye.
- The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
- The subject must not be monovision corrected.
- The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
- 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)
- The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
- The subject must not have had an eye injury within 8 weeks prior to study enrollment.
- The subject must not have had previous eye surgery.
- The subject must be successfully trial fitted with the study contact lenses.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT00717249
Start Date
August 1 2007
End Date
April 1 2008
Last Update
May 26 2016
Active Locations (20)
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1
Cole, Cole, and Krohn
Fresno, California, United States, 93704
2
Dr. James R. Dugue Family Optometrist
Mission Viejo, California, United States, 92691
3
Fukai and Associates
Louisville, Colorado, United States, 80027
4
Baymeadows Vision Center
Jacksonville, Florida, United States, 32256