Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
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|ClinicalTrials.gov Identifier: NCT00611403|
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : December 20, 2011
Last Update Posted : December 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) Drug: Artificial Tears REFRESH ENDURA®||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||June 2009|
Active Comparator: RESTASIS®
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
Active Comparator: REFRESH ENDURA®
Artificial Tears (REFRESH ENDURA®)
Drug: Artificial Tears REFRESH ENDURA®
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
- Percentage of Patients With Clinical Success at Month 6 [ Time Frame: 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.
- Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611403
|United States, Kansas|
|Overland Park, Kansas, United States|
|Study Director:||Medical Director||Allergan|