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NCT00827255 Clinical Trial

Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

Dry Eye Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00827255
Other study ID # MA-RES-08-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2009
Est. completion date October 2009

Study information
Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date October 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine Ophthalmic Emulsion 0.05%
One drop two times a day approximately 12 hours apart

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis(®) 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
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. Month 12
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. Month 12
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