Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

781 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-08-31

Brief Summary

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This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

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Detailed Description

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Conditions

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Keratoconjunctivitis Sicca

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

* cyclosporine ophthalmic emulsion 0.05%
* artificial tears

cyclosporine ophthalmic emulsion 0.05%, artificial tears

Intervention Type DRUG

one drop, twice a day in each eye

Interventions

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cyclosporine ophthalmic emulsion 0.05%, artificial tears

one drop, twice a day in each eye

Intervention Type DRUG

Other Intervention Names

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Restasis®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of dry eye disease
* Currently using artificial tears daily
* Male or female of legal age of consent
* Normal lid position and closure

Exclusion Criteria

* Patients currently using cyclosporine ophthalmic emulsion 0.05%
* Participation in other investigational drug or device study
* Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

Eligible Sex

ALL

Accepts Healthy Volunteers

No