Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cyclosporine 0.010% eye drops
Cyclosporine 0.010% eye · 1 trial · 1 indication
Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.
| Arm | Type | Description |
|---|---|---|
| Cyclosporine 0.010% eye drops | EXPERIMENTAL | Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Cyclosporine 0.005% eye drops | EXPERIMENTAL | Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Placebo (Vehicle for Cyclosporine) | PLACEBO_COMPARATOR | Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Name | Type | Description |
|---|---|---|
| Cyclosporine 0.010% eye drops | DRUG | Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Cyclosporine 0.005% eye drops | DRUG | Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery. |
| Placebo (Vehicle for Cyclosporine) | DRUG | Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-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 * Previous use of RESTASIS®