Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pittsburgh, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine ophthalmic emulsion 0.05%

Drug

One drop two times a day approximately 12 hours apart

Other names: RESTASIS®

Primary outcomes

Percentage of Patients With Complete Clearing of Corneal Staining at Month 12

Time frame: 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 outcomes

Schirmer's Test at Month 12

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 22, 2009
Registry last updated: Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed