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

Completed · Phase 3

Conditions studied: Open Angle Glaucoma and Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT04061044

Run by

Ocular Therapeutix, Inc.

People needed

40

Starts

2018-07-10

Expected to finish

2020-09-22

Last updated by the study team

2023-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ApexEye — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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