Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).

Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A; Device: galyfilcon A

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626
      • Steven S. Grant, OD
    • Fresno, California, United States, 93704
      • Cole, Cole, and Krohn
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Fukai and Associates
  • Connecticut
    • Bloomfield, Connecticut, United States, 06002
      • Peter C. Donshik, MD
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Dr. Ted Brink and Associates
    • Orlando, Florida, United States, 32803
      • Jack J. Yager, OD
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Eyecare Associates
  • Kansas
    • Gardner, Kansas, United States, 66030
      • Drs. Hawks, Besler & Rogers
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Lee Rigel
  • Missouri
    • St. Louis, Missouri, United States, 63121
      • Univ Missouri at St. Louis, College of Optometry
    • Warrensburg, Missouri, United States, 64093
      • InSight Eyecare
  • Ohio
    • Athens, Ohio, United States, 45701
      • Drs. Quinn, Quinn and Associates
    • Columbus, Ohio, United States, 43202
      • Central Ohio Eyecare
  • Oregon
    • Grants Pass, Oregon, United States, 97526
      • Kenji Hamada, OD
  • Pennsylvania
    • Moon Township, Pennsylvania, United States, 15108
      • West Hills Vision Center
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Kenneth A. Young, OD
    • Nashville, Tennessee, United States, 37205
      • Gary W. Jerkins, MD
  • Texas
    • Amarillo, Texas, United States, 79119
      • Premier Vision
    • Carrollton, Texas, United States, 75006
      • Charles Wegman, OD
    • Katy, Texas, United States, 77450
      • Wishnow-Sugar Vision Group
    • Plano, Texas, United States, 75023
      • First Eye Care Plano
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Dr. William Bogus
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Scott Jens, OD
  • 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: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject must be at least 18 years of age.
• The subject must read and sign the statement of informed consent and be provided with a copy of the form.
• Minimum of 7 days of successful lens wear
• Contact lens prescription requiring between -1.00 to -6.00 D spherical power
• Less than 1.00 D of astigmatism in either eye

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; etafilcon A contact lens being worn 7 days/6 nights.	Device: etafilcon A
Experimental: Test; galyfilcon A contact lens being worn 7 days/6 nights.	Device: galyfilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40	Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.	Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
Rate of Contact Lens Related Serious and Significant Events (SSE)	The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.	Throughout the duration of the study (1 Year)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: October 14, 2005
• First Submitted That Met QC Criteria: October 14, 2005
• First Posted (Estimate): October 18, 2005

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1480