drugset / Trial / NCT01180062

Safety Study of Latanoprost Slow Release Insert

NCT01180062

Phase 1 Terminated 12 enrolled Daniel Moore Pfizer · collab
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

EvaluationDrugModalityDoseRoute
Comparator Latanoprost Small molecule 0.5 ug Other
Comparator Latanoprost Small molecule 1 ug Other
Comparator Latanoprost Small molecule 2 ug Other