drugset / Trial / NCT01319773
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
RandomizedParallel-groupTriple-blind
Summary
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-01
- Completion
- 2011-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclosporine ophthalmic emulsion | Unknown | 0.05 % | Other |
| Subject | cyclosporine ophthalmic emulsion Formulation A | Unknown | — | Other |
| Subject | cyclosporine ophthalmic emulsion Formulation B | Unknown | — | Other |