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Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2010-11 |
| Completion | 2011-01 |
Conditions
- Dry Eye Syndromes
Interventions
- cyclosporine ophthalmic emulsion Formulation A
- cyclosporine ophthalmic emulsion Formulation B
- cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
- cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
- cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
Primary outcomes
- Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) — Day 1
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.
Countries
United States