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

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. Identifier: NCT00469573
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 1, 2008
Information provided by:
Innovative Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: 1. Optive Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
1. Drug: 1. Optive
Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Primary Outcome Measures :
  1. Safety [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 8 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00469573

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United States, New York
South Shore Eye Care
Wantagh, New York, United States, 11793
Sponsors and Collaborators
Innovative Medical
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Principal Investigator: Jodi Luchs, MD South Shore Eye Care
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Responsible Party: Jodi Luchs, MD, South Shore Eye Care Identifier: NCT00469573    
Other Study ID Numbers: 5302
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases