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A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT05335122
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Study Description
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Brief Summary:
To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: OTX-TIC low dose Travoprost Intracameral Implant Drug: OTX-TIC high dose Travoprost Intracameral Implant Drug: Durysta, Bimatoprost Intracameral Implant 10 µg Phase 2

Detailed Description:
This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Sponsor, Study Coordinator, Investigator
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: OTX-TIC Low Dose
Travoprost Intracameral Implant low dose
 Drug: OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
Experimental: OTX-TIC High Dose
Travoprost Intracameral Implant high dose
 Drug: OTX-TIC high dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
Active Comparator: Durysta
Bimatoprost Intracameral Implant 10 µg
 Drug: Durysta, Bimatoprost Intracameral Implant 10 µg
Durysta is injected into the anterior chamber of the eye.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy outcome measures [ Time Frame: Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit] ]
    IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Are 18 years of age or older at the time of screening
  • Provide written informed consent and are able to comply with all study requirements
  • Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
  • Have a negative pregnancy test result for women of childbearing potential at Baseline
  • Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

  • Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
  • Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
  • Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05335122


Contacts
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Contact: Clinical Project Manager 781-357-4000 clinicalaffairs@ocutx.com

Locations
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United States, Florida
Ocular Therapeutiux, Inc. Recruiting
Delray Beach, Florida, United States, 33484
Contact: Clinical Project Manager         
United States, Georgia
Ocular Therapeutix, Inc. Recruiting
Roswell, Georgia, United States, 30076
Contact: Clinical Project Manager         
United States, Indiana
Ocular Therapeutix Inc Recruiting
Carmel, Indiana, United States, 46032
Contact: Clinical Project Manager         
United States, Missouri
Ocular Therapeutix, Inc. Recruiting
Saint Joseph, Missouri, United States, 49085
Contact: Clinical Project Manager         
Ocular Therapeutix Inc. Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Project Manager         
United States, North Dakota
Ocular Therapeutiux, Inc. Recruiting
Fargo, North Dakota, United States, 58103
Contact: Clinical Project Manager         
United States, Oklahoma
Ocular Therapeutix Inc Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Clinical Project Manager         
United States, Texas
Ocular Therapeutix, Inc. Recruiting
Austin, Texas, United States, 78701
Contact: Clinical Project Manager         
Ocular Therapeutix, Inc. Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Project Manager         
Sponsors and Collaborators
Ocular Therapeutix, Inc.
More Information
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT05335122    
Other Study ID Numbers: OTX-TIC-2020-201
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022

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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
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Bimatoprost
Travoprost
Antihypertensive Agents