Completed
PHASE1
INTERVENTIONAL
NCT01319773
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
cyclosporine ophthalmic emulsion Formulation A
Type:
DRUG
Description:
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.
Name:
cyclosporine ophthalmic emulsion Formulation B
Type:
DRUG
Description:
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.
Name:
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
Type:
DRUG
Description:
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.
Name:
cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
Type:
DRUG
Description:
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.
Name:
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
TimeFrame:
Day 1
Description:
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.
Trial Information
NCT ID
NCT01319773
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Allergan
Last Updated
December 15, 2025