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Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

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: NCT00405457
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : February 22, 2010
Information provided by:
Innovative Medical

Brief Summary:
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Restasis, Optive Tears Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Study Start Date : November 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
A Drug: Restasis, Optive Tears
Restasis and Optive Tears use twice daily more frequently if needed

Primary Outcome Measures :
  1. efficacy [ Time Frame: 1 yr 3 months ]

Secondary Outcome Measures :
  1. dry eye symptoms [ Time Frame: 1 yr 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • · Males or females > 18 years old

    • Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
    • Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

  • · Patients using Restasis® for less than 3 months.

    • Known contraindications to any study medication or ingredients
    • Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
    • Other active uncontrolled ocular diseases or uncontrolled systemic disease

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): NCT00405457

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United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Innovative Medical
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Principal Investigator: David Hardten, MD Minnesota Eye Consultants
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Responsible Party: David Hardten, MD, Minnesota Eye Consultants Identifier: NCT00405457    
Other Study ID Numbers: 5261
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: February 22, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors