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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received Restasis® | Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% | Drug | One drop two times a day approximately 12 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Clearing of Corneal Staining at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's Test at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pittsburgh | Pennsylvania | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23226002 | Background | Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28. |
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Retrospective analysis. Patients may have been treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) in addition to other medications during the course of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Who Received Restasis® | Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Who Received Restasis® | Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Complete Clearing of Corneal Staining at 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. | ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline. | Posted | Number | Percentage of Patients | Month 12 |
|
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Serious adverse events and adverse events were not collected directly as this was a retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Who Received Restasis® | Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Schirmer's Test at 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. | ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded. | Posted | Month 12 |
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| 0 |
| 0 |
| 0 |
| 0 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D000602 |
| Amino Acids, Peptides, and Proteins |