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

Allergan

Status: Completed

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

Study type: Observational

Funder types: Industry

Identifiers

NCT00717418

R.E.S.T.O.R.E.

Details and patient eligibility

About

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.

Enrollment: 781 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

781 participants in 1 patient group

1

Description:

* cyclosporine ophthalmic emulsion 0.05% * artificial tears

Treatment:

Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears