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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).

This study has been completed.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc. Identifier:
First received: October 14, 2005
Last updated: February 24, 2016
Last verified: February 2016
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 Intervention
Device: etafilcon A
Device: galyfilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.

  • Rate of Contact Lens Related Serious and Significant Events (SSE) [ Time Frame: Throughout the duration of the study (1 Year) ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 504
Study Start Date: September 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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:

  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 identifier: NCT00241280

  Show 25 Study Locations
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc. Identifier: NCT00241280     History of Changes
Other Study ID Numbers: CR-1480 
Study First Received: October 14, 2005
Results First Received: December 4, 2015
Last Updated: February 24, 2016
Health Authority: United States: Food and Drug Administration processed this record on October 25, 2016