NCT01319773

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	cyclosporine ophthalmic emulsion Formulation A	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.
DRUG	cyclosporine ophthalmic emulsion Formulation B	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.
DRUG	cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%	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.
DRUG	cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%	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.
DRUG	cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-03-22
• Last updated: 2015-09-07
• Results posted: 2012-03-02

Locations

1 site across 1 country: United States