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Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

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ClinicalTrials.gov Identifier: NCT02914509
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
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

Detailed Description:
This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 565 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 (sustained release travoprost) Intracanalicular Depot
OTX-TP (sustained release travoprost) Intracanalicular Depot
 Drug: Travoprost
Placebo Comparator: PV (Placebo Vehicle) Intracanalicular Depot
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. Number of Participants With Serious Adverse Events [ Time Frame: Through study completion, an average of 23 months ]
    Number of Participants with Serious Adverse Events


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.
  Study Documents (Full-Text)

Documents provided by Ocular Therapeutix, Inc.:
Study Protocol  [PDF] May 2, 2017
Statistical Analysis Plan  [PDF] January 2, 2018

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
Results First Posted: October 11, 2021
Last Update Posted: October 11, 2021
Last Verified: September 2021
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