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

Verified by: Innovative Medical, February 2010
First Received: November 28, 2006 | Last Updated: February 19, 2010 | Phase: Phase 4 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 50
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

  • Drug: Restasis, Optive Tears
    • Restasis and Optive Tears use twice daily more frequently if needed

Arms, Groups and Cohorts in this Clinical Trial

  • Other: A

Outcome Measures for this Clinical Trial

Primary Measures

  • efficacy
    • Time Frame: 1 yr 3 months
      Safety Issue?: No

Secondary Measures

  • dry eye symptoms
    • Time Frame: 1 yr 3 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Innovative Medical Industry

Overall Clinical Trial Officials and Contacts

David Hardten, MD Principal Investigator Minnesota Eye Consultants  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405457

Study ID Number: 5261

ClinicalTrials.gov Identifier: NCT00405457

Health Authority: United States: Institutional Review Board

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