Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

April 10, 2019 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • RESTASIS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-RES-08-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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