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OpenTrials
Completed

NCT Number: NCT04061044

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

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.

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Key information

Conditions

Open Angle Glaucoma and Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ApexEye

Cincinnati, Ohio, 45242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ophthalmic Insert

Drug

Travoprost, 0.32 mg

Other names: OTX-TP

Primary outcomes

  1. Incidence of Treatment-Related Adverse Events (Safety and Tolerability)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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