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Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

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ClinicalTrials.gov Identifier: NCT00399061
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
Innovative Medical

Brief Summary:
The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Study Start Date : November 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Systane
Drug: Systane, Optive, Restasis
Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Active Comparator: 2
Optive
Drug: Systane, Optive, Restasis
Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Placebo Comparator: 3
Restasis
Drug: Systane, Optive, Restasis
Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed




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

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


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

Inclusion Criteria:

  • · Males or females > 18 years old

    • Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
    • At least Grade 2 conjunctival staining
    • Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

  • · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)

    • Current use of topical cyclosporine
    • 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.
    • Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
    • Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
    • Ocular surgery within the past 3 months,
    • Active ocular allergies

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): NCT00399061


Locations
United States, New York
Dr. Schultze
Slingerlands, New York, United States, 12159
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Robert Schultze, MD Slingerlands Medical Building

Responsible Party: Robert Schultze, MD, Slingerlands Medical Building
ClinicalTrials.gov Identifier: NCT00399061     History of Changes
Other Study ID Numbers: 5278
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

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