Vistakon Investigational Contact Lenses Worn for Daily Wear
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 529
- Locations
- 20
- Primary Endpoint
- Subject Reported Symptoms
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study compares the performance of an investigational contact lens to a currently marketed lens.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Subject Reported Symptoms
Time Frame: 6 months
Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Average Contact Lens Wear Time
Time Frame: 6 Months
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Slit Lamp Findings
Time Frame: 6 months
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Visual Acuity
Time Frame: 6 months
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.