- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827255
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
-
-
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%)
|
One drop two times a day approximately 12 hours apart
Other Names:
|
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
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.
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
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eye Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
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.
Clinical Trials on Dry Eye Disease
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
Gordon Schanzlin New VisionRecruitingDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
LantibioRiver Plate Biotechnology, Inc.; Rx Development Resources, LLCCompletedSafety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye SyndromeDry Eye DiseaseUnited States
-
Fundación Oftalmológica Los AndesAlcon ResearchNot yet recruitingCataract | Dry Eye Syndrome | Dry Eye Disease | Phacoemulsification | Evaporative Dry Eye
-
Vienna Institute for Research in Ocular SurgeryTerminated
-
Novaliq GmbHCompletedDry Eye Disease (DED)United States
-
Oyster Point Pharma, Inc.CompletedDry Eye Disease (DED)United States
-
Novaliq GmbHCompletedDry Eye Disease (DED)United States
Clinical Trials on Cyclosporine Ophthalmic Emulsion 0.05%
-
AllerganCompletedDry Eye SyndromesUnited States
-
Taejoon Pharmaceutical Co., Ltd.CompletedDry Eye | Dry Eye SyndromesKorea, Republic of
-
Aurinia Pharmaceuticals Inc.Completed
-
AllerganCompleted
-
AllerganCompletedPterygiumSingapore, United States, Australia
-
AllerganCompletedKeratoconjunctivitis SiccaUnited States
-
AllerganCompletedDry Eye SyndromesUnited States
-
AllerganCompletedArthritis, Rheumatoid | Lupus Erythematosus, Systemic | Scleroderma, Systemic | Keratoconjunctivitis Sicca | Sjogren's SyndromeUnited States
-
Baylor College of MedicineAllerganTerminatedDry EyeUnited States