Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2010 |
| End Date: | January 2011 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
