Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

NCT ID: NCT00827255

Last Updated: 2019-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients who received Restasis®

Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)

Cyclosporine Ophthalmic Emulsion 0.05%

Intervention Type DRUG

One drop two times a day approximately 12 hours apart

Interventions

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Cyclosporine Ophthalmic Emulsion 0.05%

One drop two times a day approximately 12 hours apart

Intervention Type DRUG

Other Intervention Names

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RESTASIS®

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23226002 (View on PubMed)

Other Identifiers

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MA-RES-08-002

Identifier Type: -

Identifier Source: org_study_id

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