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

Phase 3

Completed

• Conditions: Open Angle Glaucoma and Ocular Hypertension
• Interventions: Drug: Ophthalmic Insert

• Registration Number: NCT04061044
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Primary Completion: 2020-02-10
• Study Completion: 2020-09-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Ophthalmic Insert	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)	12 months

Trial Locations

Locations (1)

ApexEye; 🇺🇸 Cincinnati, Ohio, United States