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Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469573
First Posted: May 4, 2007
Last Update Posted: April 1, 2008
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.
Information provided by:
Innovative Medical
  Purpose
The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Condition Intervention Phase
Dry Eye Drug: 1. Optive Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 8 months ]

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Drug: 1. Optive
Optive 15ml- (in the eye) Instill one drop twice daily in each eye

  Eligibility

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:

  • Men and women 18 and over

    • Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
    • Complaint of dry eyes
    • OSDI score > 23

Exclusion Criteria:

  • Use of RGP or PMMA contact lenses

    • Poorly fitting contact lenses
    • Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
    • Concurrent use of topical medications other than study medications
    • Use of systemic medications with ocular drying sequelae:

      • Antihistamines
      • Decongestants
      • Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days
  Contacts and Locations
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): NCT00469573


Locations
United States, New York
South Shore Eye Care
Wantagh, New York, United States, 11793
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Jodi Luchs, MD South Shore Eye Care
  More Information

Responsible Party: Jodi Luchs, MD, South Shore Eye Care
ClinicalTrials.gov Identifier: NCT00469573     History of Changes
Other Study ID Numbers: 5302
First Submitted: May 2, 2007
First Posted: May 4, 2007
Last Update Posted: April 1, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases