Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

This study is ongoing, but not recruiting participants.

First Received: January 20, 2009 No Changes Posted

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00827255

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 Opthalmic Emulsion 0.05% but discontinued use after less than 6 weeks of treatment.

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

MedlinePlus related topics: Eye Diseases

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective

Further study details as provided by Allergan:

Primary Outcome Measures:

Corneal Staining [ Time Frame: Month 6 and Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Schirmers Test [ Time Frame: Month 6 and Month 12 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Restasis patients	Drug: Cyclosporine Ophthalmic Emulsion 0.05% One drop two times a day approximately 12 hours apart

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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 6 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 6 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, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MA-RES-08-002
Study First Received:	January 20, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00827255 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Clotrimazole
Miconazole
Antifungal Agents

Eye Diseases
Tioconazole
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Enzyme Inhibitors

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 06, 2009