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OTX-16-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-TP in Subjects With Open-Angle Glaucoma and Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02914509
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Study Description
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Brief Summary:
The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of 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 Ocular Hypertension Drug: Travoprost Other: Placebo Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

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-TP
OTX-TP (sustained release travoprost) Intracanalicular Depot
 Drug: Travoprost
Placebo Comparator: PV
PV (Placebo Vehicle) Intracanalicular Depot
 Other: Placebo Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit ]
  2. Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit ]
  3. Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit ]

Other Outcome Measures:
  1. Best corrected visual acuity [ Time Frame: Study duration ]
  2. Slit lamp biomicroscopy [ Time Frame: Study duration ]
  3. Assessment and grade of ocular hyperemia [ Time Frame: Study duration ]
  4. Subject ocular comfort assessment [ Time Frame: Study duration ]
  5. Dilated fundus examination [ Time Frame: Study duration ]
  6. Adverse events [ Time Frame: Study duration ]

Eligibility Criteria
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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:

  • Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
  • IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

  • Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
  • A history of an inadequate response or no response to topical prostaglandin
  • Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
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): NCT02914509


Locations
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United States, California
Artesia, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Lakeland, Florida, United States
United States, Georgia
Morrow, Georgia, United States
United States, Kansas
Shawnee Mission, Kansas, United States
United States, Missouri
Des Peres, Missouri, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Ocular Therapeutix, Inc.
More Information
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02914509    
Other Study ID Numbers: OTX-16-002
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Travoprost
Antihypertensive Agents