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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00241280
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : February 25, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Myopia Device: etafilcon A Device: galyfilcon A

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : September 2005
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 [ Time Frame: 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.

  2. Rate of Contact Lens Related Serious and Significant Events (SSE) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241280


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Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00241280     History of Changes
Other Study ID Numbers: CR-1480
First Posted: October 18, 2005    Key Record Dates
Results First Posted: February 25, 2016
Last Update Posted: March 24, 2016
Last Verified: February 2016