Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®); Drug: Artificial Tears REFRESH ENDURA®

• Registration Number: NCT00611403
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2011-11
• Results First Submitted: 2011-11-17
• Results First Submitted QC: 2011-11-17
• Last Update Submitted: 2011-11-17
• Results First Posted: 2011-12-20
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Patient is scheduled for bilateral LASIK surgery
• Patient is in good general health
• Eye glasses prescription of -1 to -8

Exclusion Criteria

• Significant Dry Eye
• Presence of eye disease
• Uncontrolled systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RESTASIS®	Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®	Artificial Tears REFRESH ENDURA®	Artificial Tears (REFRESH ENDURA®)

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Clinical Success at Month 6	Month 6	Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6	Baseline, Month 6	Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).
Change From Baseline in Goblet Cell Density of the Eyes at Month 6	Baseline, Month 6	Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).