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Completed

NCT Number: NCT04360174

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ocular Therapeutix, Inc., Petaluma, California, United States

Loading trial locations.

About this study

This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
  • Have IOP that is currently controlled as assessed by the Investigator
  • Have open, normal appearing anterior chamber angles as determined by gonioscopy

Exclusion criteria

  • Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
  • Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products

Treatment and study plan

OTX-TIC

Drug

OTX-TIC implant is injection in the anterior chamber of the eye

Primary outcomes

  1. Ocular Treatment Emergent Adverse Events

    Time frame: Through study completion, 6 months

    All adverse events will be captured throughout the study

  2. Efficacy Outcome

    Time frame: Diurnal IOP [12 Week Visit]

    IOP measurements at 8 am

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Oct 1, 2024

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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