Vistakon Investigational Contact Lenses Worn for Daily Wear

Completed · Not applicable

Conditions studied: Myopia

In brief

This study compares the performance of an investigational contact lens to a currently marketed lens.

Key facts

Study ID

NCT00717249

Run by

Johnson & Johnson Vision Care, Inc.

People needed

529

Starts

2007-08-01

Expected to finish

2008-04-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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