Conditions: Dry Eye Syndromes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A arm 2: PGP: cyclosporine ophthalmic emulsion Formulation B arm 3: Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% arm 4: PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% arm 5: PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B

Interventions: intervention 1: cyclosporine ophthalmic emulsion Formulation A intervention 2: cyclosporine ophthalmic emulsion Formulation B intervention 3: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% intervention 4: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% intervention 5: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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.

Protocol document: