drugset / Trial / NCT01180062
Safety Study of Latanoprost Slow Release Insert
RandomizedFactorialOpen-labelTreatment
Summary
This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. The first cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus achieving twice the drug levels compared to cohort I and third cohort will receive high dose drug insert.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Latanoprost | Small molecule | 0.5 ug | Other |
| Comparator | Latanoprost | Small molecule | 1 ug | Other |
| Comparator | Latanoprost | Small molecule | 2 ug | Other |