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

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.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca
• Intervention / Treatment: Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

• Study Type: Observational
• Enrollment (Actual): 781

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilson, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients can either:

1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment
2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; cyclosporine ophthalmic emulsion 0.05%; artificial tears	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears; one drop, twice a day in each eye; Other Names: Restasis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index (OSDI) Total Score at 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).	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer's Test With and Without Anesthesia at Baseline	Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.	Baseline

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins; Lubricant Eye Drops
• Other Study ID Numbers: R.E.S.T.O.R.E.