Topical Cyclosporine and Disease Progression

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00567983
First received: December 3, 2007
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.


Condition Intervention Phase
Disease Progression
Disease Severity
Staining
Schirmers
OSDI
Drug: Restasis
Drug: Endura
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Topical Cyclosporine and Disease Progression

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Disease Severity [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Staining [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Drug: Restasis
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
Placebo Comparator: 2. Drug: Endura
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567983

Locations
United States, Illinois
Lakeside Eye Clinic
Chicago, Illinois, United States, 60641
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Sanjay Rao Lakeside Eye Clinic
  More Information

No publications provided

Responsible Party: Sanjay Rao, MD, Lakeside Eye Clinic
ClinicalTrials.gov Identifier: NCT00567983     History of Changes
Other Study ID Numbers: 13717A
Study First Received: December 3, 2007
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease Progression
Disease Attributes
Pathologic Processes
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014