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

September 26, 2024 updated by: Ocular Therapeutix, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Petaluma, California, United States, 94954
        • Ocular Therapeutix, Inc.
      • Torrance, California, United States, 90505
        • Ocular Therapeutix, Inc.
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Ocular Therapeutix, Inc
    • Texas
      • Austin, Texas, United States, 78731
        • Ocular Therapeutix, Inc.
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • Ocular Therapeutix, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-TIC-Cohort 1
15 µg (formulation1) implant
Drug: OTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 2
26 µg (formulation1) implant
Drug: OTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 3
15 µg (formulation 2) implant
Drug: OTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 4
5 µg (formulation 3) implant
Drug: OTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Treatment Emergent Adverse Events
Time Frame: Through study completion, 6 months
All adverse events will be captured throughout the study
Through study completion, 6 months
Efficacy Outcome
Time Frame: Diurnal IOP [12 Week Visit]
IOP measurements at 8 am
Diurnal IOP [12 Week Visit]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

May 24, 2021

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-Protocol-0045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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