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Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00827255
First received: January 20, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.


Condition Intervention
Dry Eye Disease
 Drug: Cyclosporine Ophthalmic Emulsion 0.05%

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Complete Clearing of Corneal Staining at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.


Secondary Outcome Measures:
  • Schirmer's Test at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.


Enrollment: 35
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who received Restasis®
Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
 Drug: Cyclosporine Ophthalmic Emulsion 0.05%
One drop two times a day approximately 12 hours apart
Other Name: RESTASIS®

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The medical charts of all chronic dry eye patients who discontinued their first trial of RESTASIS® after less than 12 weeks of treatment and who started a second trial of RESTASIS® prior to June 1, 2008 will be included in the review.

Criteria

Inclusion Criteria:

  • Adults >16 years of age
  • Dry eye patients
  • Subject with history of less than 12 weeks of initial RESTASIS® treatment
  • Subject started second trial of RESTASIS® treatment prior to June 1, 2008
  • First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

Exclusion Criteria:

  • Patients with Contact Lens Intolerance
  • Patients with Ocular Rosacea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827255

Locations
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00827255     History of Changes
Other Study ID Numbers: MA-RES-08-002
Study First Received: January 20, 2009
Results First Received: October 17, 2011
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Diseases
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 May 19, 2013