Safety Study of Latanoprost Slow Release Insert

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

Outcome

Outcome not reported

Stopped: “Study terminated early due to manufacturer not replenishing study site supply of inserts, despite repeated requests for more inserts.”

Drugs

Indications