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).
- Conditions
- Myopia
- Interventions
- Device: galyfilcon ADevice: etafilcon A
- Registration Number
- NCT00241280
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test galyfilcon A galyfilcon A contact lens being worn 7 days/6 nights. Control etafilcon A etafilcon A contact lens being worn 7 days/6 nights.
- Primary Outcome Measures
Name Time Method Rate of Contact Lens Related Serious and Significant Events (SSE) Throughout the duration of the study (1 Year) 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.
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Cole, Cole, and Krohn
🇺🇸Fresno, California, United States
Fukai and Associates
🇺🇸Louisville, Colorado, United States
Peter C. Donshik, MD
🇺🇸Bloomfield, Connecticut, United States
Scott Jens, OD
🇺🇸Middleton, Wisconsin, United States
Steven S. Grant, OD
🇺🇸Costa Mesa, California, United States
Kenneth A. Young, OD
🇺🇸Brentwood, Tennessee, United States
Kenji Hamada, OD
🇺🇸Grants Pass, Oregon, United States
Drs. Quinn, Quinn and Associates
🇺🇸Athens, Ohio, United States
InSight Eyecare
🇺🇸Warrensburg, Missouri, United States
First Eye Care Plano
🇺🇸Plano, Texas, United States
Jack J. Yager, OD
🇺🇸Orlando, Florida, United States
Central Ohio Eyecare
🇺🇸Columbus, Ohio, United States
Clayton Eye Center
🇺🇸Morrow, Georgia, United States
Eyecare Associates
🇺🇸Bloomington, Illinois, United States
Charles Wegman, OD
🇺🇸Carrollton, Texas, United States
Drs. Hawks, Besler & Rogers
🇺🇸Gardner, Kansas, United States
Snowy Range Vision Center
🇺🇸Laramie, Wyoming, United States
Gary W. Jerkins, MD
🇺🇸Nashville, Tennessee, United States
Dr. William Bogus
🇺🇸Salt Lake City, Utah, United States
West Hills Vision Center
🇺🇸Moon Township, Pennsylvania, United States
Wishnow-Sugar Vision Group
🇺🇸Katy, Texas, United States
Dr. Ted Brink and Associates
🇺🇸Jacksonville, Florida, United States
Univ Missouri at St. Louis, College of Optometry
🇺🇸St. Louis, Missouri, United States
Premier Vision
🇺🇸Amarillo, Texas, United States
Lee Rigel
🇺🇸East Lansing, Michigan, United States