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

Ocular Therapeutix

Status and phase

Completed

Phase 3

Conditions

Open Angle Glaucoma and Ocular Hypertension

Treatments

Drug: Ophthalmic Insert

Study type

Interventional

Funder types

Industry

Identifiers

NCT04061044

CLN-Protocol-0047

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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