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

Open Angle Glaucoma and Ocular Hypertension Clinical Trial

Official title:

A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061044
• Other study ID #: CLN-Protocol-0047
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2018
• Est. completion date: September 22, 2020

Study information

• Verified date: June 2023
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 22, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma and Ocular Hypertension

Intervention

Drug:
• Ophthalmic Insert
Travoprost, 0.32 mg

Locations

Country	Name	City	State
United States	ApexEye	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Related Adverse Events (Safety and Tolerability)		12 months