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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allergan
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

Parallel-Group Phase:

• Weigh at least 110 lbs

• 18 to 45 years old

Paired-Eye Phase:

• Dry eye disease in both eyes

Exclusion Criteria:

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