Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®), cyclosporine ophthalmic emulsion 0.05%
Cyclosporine Emulsion 0.05% · 2 trials · 2 indications
Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
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 |
|---|---|---|
| cyclosporine ophthalmic emulsion 0.05% | EXPERIMENTAL | One drop in the study eye (or eyes) administered four times daily (QID) |
| Vehicle | PLACEBO_COMPARATOR | One drop in the study eye (or eyes) administered four times daily (QID) |
| 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% | DRUG | One drop in the study eye (or eyes) administered four times daily (QID) |
| Vehicle | DRUG | One drop in the study eye (or eyes) administered four times daily (QID) |
| 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: * Have a pterygium in at least one eye that has not been previously removed with surgery Exclusion Criteria: * Uncontrolled systemic disease * Active eye disease * Current or anticipated use of topical eye medications other than artificial tears. * Anticipated wearing of conta...
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