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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04061044
Recruitment Status : Completed
First Posted : August 19, 2019
Last Update Posted : August 17, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma and Ocular Hypertension Drug: Ophthalmic Insert Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Treatment Drug: Ophthalmic Insert
Travoprost, 0.32 mg
Other Name: OTX-TP

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 months ]
  2. Subject ocular comfort assessment [ Time Frame: 12 months ]
  3. Best corrected visual acuity (BCVA) [ Time Frame: 12 months ]
  4. Slit lamp biomicroscopy including assessment and grade of ocular hyperemia (at slit lamp) and punctum exam [ Time Frame: 12 months ]
  5. Measurement of Intraocular pressure (IOP) [ Time Frame: 12 months ]
  6. Fundus examination [ Time Frame: 12 months ]
  7. Optical Coherence Tomography of optic nerve on nerve fiber layer [ Time Frame: 12 months ]
  8. Automated perimetry [ Time Frame: 12 months ]
  9. Number of subjects who need rescue therapy over the study period [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04061044

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United States, Ohio
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Ocular Therapeutix, Inc.
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Responsible Party: Ocular Therapeutix, Inc. Identifier: NCT04061044    
Other Study ID Numbers: CLN-Protocol-0047
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases