Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Cyclosporine Ophthalmic Emulsion 0.05%

• Registration Number: NCT00827255
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Primary Completion: 2009-06
• Study Completion: 2009-10
• Results First Submitted: 2011-10-17
• Results First Submitted QC: 2012-07-16
• Results First Posted: 2012-07-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who received Restasis®	Cyclosporine Ophthalmic Emulsion 0.05%	Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Complete Clearing of Corneal Staining at Month 12	Month 12	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

Name	Time	Method
Schirmer's Test at Month 12	Month 12	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.