Clinical trial NCT00717249: Vistakon Investigational Contact Lenses Worn for Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. The subject must be at least 18 years of age.
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:

1. 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.
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.

Primary outcomes:
measure: Slit Lamp Findings
timeFrame: 6 months
measure: Subject Reported Symptoms
timeFrame: 6 months
measure: Visual Acuity
timeFrame: 6 months
measure: Average Contact Lens Wear Time
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Cole, Cole, and Krohn
state: California
city: Mission Viejo
country: United States
facility: Dr. James R. Dugue Family Optometrist
state: California
city: Louisville
country: United States
facility: Fukai and Associates
state: Colorado
city: Jacksonville
country: United States
facility: Baymeadows Vision Center
state: Florida
city: Bloomington
country: United States
facility: Eyecare Associates
state: Illinois
city: Neodesha
country: United States
facility: Advantage Eyecare Associates, LLC
state: Kansas
city: Warrensburg
country: United States
facility: InSight Eyecare
state: Missouri
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Athens
country: United States
facility: Drs. Quinn, Quinn and Associates
state: Ohio
city: Chagrin Falls
country: United States
facility: Dr. Michael H. Greenburg, Inc.
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Eyecare
state: Ohio
city: North Olmsted
country: United States
facility: James W. Kershaw OD, Inc.
state: Ohio
city: Moon Township
country: United States
facility: West Hills Vision Center
state: Pennsylvania
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
city: Wyomissing
country: United States
facility: Research Across America
state: Pennsylvania
city: Warwick
country: United States
facility: Dr. David W. Ferris and Associates
state: Rhode Island
city: Amarillo
country: United States
facility: Premier Vision
state: Texas
city: Salt Lake City
country: United States
facility: William J. Bogus OD
state: Utah
city: Virginia Beach
country: United States
facility: The Eye Speciliasts, Ltd
state: Virginia
city: Laramie
country: United States
facility: Snowy Range Vision Center
state: Wyoming
Study officials:
References: