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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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Cyclosporine emulsion Formulation A is an investigational ophthalmic emulsion containing cyclosporine, developed by AbbVie Inc. (ticker ABBV) for dry eye syndromes. It is a small molecule formulation designed for topical eye use and has been studied in a Phase 1 clinical trial.
Cyclosporine emulsion Formulation A is being developed for the treatment of dry eye syndromes. It is an ophthalmic emulsion intended for topical administration to the eye, and its only recorded clinical trial enrolled patients with dry eye as well as healthy volunteers.
Cyclosporine emulsion Formulation A targets PPIA (peptidylprolyl isomerase A), also known as cyclophilin A. It acts as a modulator of this target. The active molecule, cyclosporine, is a small molecule, and the emulsion is formulated for ophthalmic delivery.
Cyclosporine emulsion Formulation A is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development of this ophthalmic emulsion formulation for dry eye syndromes.
Cyclosporine emulsion Formulation A is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The single recorded trial, NCT01319773, has been completed.
Cyclosporine emulsion Formulation A has been studied in one completed Phase 1 trial, NCT01319773, titled "Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye." The trial enrolled 44 participants in the United States and was randomized, double-blind, and controlled.
Yes, cyclosporine emulsion Formulation A is also known as cyclosporine ophthalmic emulsion Formulation A. Both names refer to the same investigational product developed by AbbVie Inc. for dry eye syndromes, and the ophthalmic designation reflects its topical eye formulation.