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Vistakon Investigational Contact Lenses Worn for Daily Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT00717249
First received: July 15, 2008
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
This study compares the performance of an investigational contact lens to a currently marketed lens.

Condition Intervention
Myopia
Device: galyifilcon A control lens
Device: galyfilcon A with a silver additive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Subject Reported Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.

  • Average Contact Lens Wear Time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 529
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Lens
galyfilcon A contact lens with a silver additive
Device: galyfilcon A with a silver additive
Investigational daily wear contact lens
Active Comparator: Control Lens
galyfilcon A control contact lens
Device: galyifilcon A control lens
Marketed daily wear contact lens
Other Name: ACUVUE Advance with Hydraclear

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717249

Locations
United States, California
Cole, Cole, and Krohn
Fresno, California, United States, 93704
Dr. James R. Dugue Family Optometrist
Mission Viejo, California, United States, 92691
United States, Colorado
Fukai and Associates
Louisville, Colorado, United States, 80027
United States, Florida
Baymeadows Vision Center
Jacksonville, Florida, United States, 32256
United States, Illinois
Eyecare Associates
Bloomington, Illinois, United States, 61701
United States, Kansas
Advantage Eyecare Associates, LLC
Neodesha, Kansas, United States, 66757
United States, Missouri
InSight Eyecare
Warrensburg, Missouri, United States, 64093
United States, New York
Spectrum Eyecare
Jamestown, New York, United States, 14750
United States, Ohio
Drs. Quinn, Quinn and Associates
Athens, Ohio, United States, 45701
Dr. Michael H. Greenburg, Inc.
Chagrin Falls, Ohio, United States, 44023
Central Ohio Eyecare
Columbus, Ohio, United States, 43202
James W. Kershaw OD, Inc.
North Olmsted, Ohio, United States, 44070
United States, Pennsylvania
West Hills Vision Center
Moon Township, Pennsylvania, United States, 15108
Nittany Eye Associates
State College, Pennsylvania, United States, 16801
Research Across America
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
Dr. David W. Ferris and Associates
Warwick, Rhode Island, United States, 02886
United States, Texas
Premier Vision
Amarillo, Texas, United States, 79119
United States, Utah
William J. Bogus OD
Salt Lake City, Utah, United States, 84106
United States, Virginia
The Eye Speciliasts, Ltd
Virginia Beach, Virginia, United States, 23455
United States, Wyoming
Snowy Range Vision Center
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00717249     History of Changes
Other Study ID Numbers: CR-1513 
Study First Received: July 15, 2008
Results First Received: April 20, 2016
Last Updated: April 20, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 27, 2016