Approval Probability
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Adjusted LOA
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Also known as cyclosporine ophthalmic emulsion Formulation A
cyclosporine emulsion Formulation A · 1 trial · 1 indication
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
| Arm | Type | Description |
|---|---|---|
| cyclosporine ophthalmic emulsion Formulation A (Formulation A) | EXPERIMENTAL | Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A |
| cyclosporine ophthalmic emulsion Formulation B (Formulation B) | EXPERIMENTAL | PGP: cyclosporine ophthalmic emulsion Formulation B |
| Formulation A and cyclosporine ophthalmic emulsion 0.05% | OTHER | Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% |
| Formulation B and cyclosporine ophthalmic emulsion 0.05% | OTHER | PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% |
| Formulation A and Formulation B | EXPERIMENTAL | PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B |
| Name | Type | Description |
|---|---|---|
| cyclosporine ophthalmic emulsion Formulation A | DRUG | One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3. |
| cyclosporine ophthalmic emulsion Formulation B | DRUG | One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3. |
| cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% | DRUG | One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. |
| cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% | DRUG | One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day. |
| cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B | DRUG | One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day. |
Inclusion Criteria: Parallel-Group Phase: * Weigh at least 110 lbs * 18 to 45 years old Paired-Eye Phase: * Dry eye disease in both eyes Exclusion Criteria: Parallel-Group Phase: * Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice wit...
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