Vistakon Investigational Contact Lenses Worn for Daily Wear

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: galyfilcon A with a silver additive; Device: galyifilcon A control lens

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: ACUVUE Advance with Hydraclear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings	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.	6 months
Subject Reported Symptoms	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.	6 months
Visual Acuity	Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.	6 months
Average Contact Lens Wear Time	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.	6 Months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1513