A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

• Status: Completed
• Trial end date: 2020-09-22
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Treatments: Travoprost

Criteria

Inclusion Criteria:

• Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial

• Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year

• Have provided written informed consent, approved by the appropriate Institutional Review Board

Exclusion Criteria:

• Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial

• Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)

• Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)

• Missed more than 2 visits during participation in the OTX-16-002 trial