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

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

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
* Drug: Artificial Tears REFRESH ENDURA®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RESTASIS®<br>Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) | Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)<br>* Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery<br>|
| Active Comparator: REFRESH ENDURA®<br>Artificial Tears (REFRESH ENDURA®) | Drug: Artificial Tears REFRESH ENDURA®<br>* REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Clinical Success at 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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at 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). | Baseline, Month 6 | 
| Change From Baseline in Goblet Cell Density of the Eyes at 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). | Baseline, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK