Phase 1
Completed N=44
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01319773 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) — NA; NA; NA; NA Nanogram/milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP) |
3; 1 | — |
| SECONDARY Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1 |
2; 1; 1; 0; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01319773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.