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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Systane, Optive, Restasis

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Slingerlands, New York, United States, 12159
      • Dr. Schultze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy	1 yr 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Dry eye symptoms	1yr 3 months

Collaborators and Investigators

• Sponsor: Innovative Medical
• Investigators: Principal Investigator: Robert Schultze, MD, Slingerlands Medical Building

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 9, 2006
• First Submitted That Met QC Criteria: November 9, 2006
• First Posted (Estimate): November 14, 2006

Study Record Updates

• Last Update Posted (Estimate): September 25, 2008
• Last Update Submitted That Met QC Criteria: September 23, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 5278