NCT01800175

Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in order to assess retention and replacement of the OTX Punctum Plug for this duration. At the Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum Plug is removed.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	Punctum Plug

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-01
• First posted: 2013-02-27
• Last updated: 2016-02-11