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

Completed · Phase 1

Conditions studied: Dry Eye Syndromes

In brief

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.

Key facts

Study ID

NCT01319773

Run by

Allergan

People needed

44

Starts

2010-11-01

Expected to finish

2011-01-01

Last updated by the study team

2015-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parallel-Group Phase:
• Weigh at least 110 lbs
• 18 to 45 years old
• Paired-Eye Phase:
• Dry eye disease in both eyes

You may not qualify if…

• Parallel-Group Phase:
• Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
• Has donated blood within 90 days
• Significant weight change (over 10 lbs) within 60 days
• Previous use of RESTASIS®
• Parallel-Group and Paired-Eye Phases:
• Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
• Consumption of alcohol products within 72 hours
• Paired-Eye Phase:
• Previous ocular surgery
• Use of RESTASIS® within 30 days

Where it is running

• Study site — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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