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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00399061
First received: November 9, 2006
Last updated: September 23, 2008
Last verified: September 2008
History of Changes

November 9, 2006
September 23, 2008
November 2006
September 2008   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 1 yr 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00399061 on ClinicalTrials.gov Archive Site
Dry eye symptoms [ Time Frame: 1yr 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye
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: 1
    Systane
    Intervention: Drug: Systane, Optive, Restasis
  • Active Comparator: 2
    Optive
    Intervention: Drug: Systane, Optive, Restasis
  • Placebo Comparator: 3
    Restasis
    Intervention: Drug: Systane, Optive, Restasis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399061
5278
Not Provided
Robert Schultze, MD, Slingerlands Medical Building
Innovative Medical
Not Provided
Principal Investigator: Robert Schultze, MD Slingerlands Medical Building
Innovative Medical
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP