Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00611403 | Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients | PHASE2 | COMPLETED | 137 | — | — | Dec 1, 2007 | Jun 1, 2009 | Dec 20, 2011 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| RESTASIS® | ACTIVE_COMPARATOR | Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) |
| REFRESH ENDURA® | ACTIVE_COMPARATOR | Artificial Tears (REFRESH ENDURA®) |
| Name | Type | Description |
|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) | DRUG | Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery |
| Artificial Tears REFRESH ENDURA® | DRUG | REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery |
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