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

Completed

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

• Registration Number: NCT00717418
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-08
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Study Completion: 2008-08
• Status Verified: 2011-12
• Results First Submitted: 2011-12-05
• Results First Submitted QC: 2011-12-05
• Last Update Submitted: 2011-12-05
• Results First Posted: 2012-01-12
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 781

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	cyclosporine ophthalmic emulsion 0.05%, artificial tears	* cyclosporine ophthalmic emulsion 0.05% * artificial tears

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI) Total Score at Baseline	Baseline	The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).