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

NCT ID: NCT02914509

Last Updated: 2021-10-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

565 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2019-03-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OTX-TP (sustained release travoprost) Intracanalicular Depot

OTX-TP (sustained release travoprost) Intracanalicular Depot

Group Type EXPERIMENTAL

Travoprost

Intervention Type DRUG

PV (Placebo Vehicle) Intracanalicular Depot

PV (Placebo Vehicle) Intracanalicular Depot

Group Type PLACEBO_COMPARATOR

Placebo Vehicle

Intervention Type OTHER

Interventions

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Travoprost

Intervention Type DRUG

Placebo Vehicle

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Artesia, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

Lakeland, Florida, United States

Site Status

Morrow, Georgia, United States

Site Status

Shawnee Mission, Kansas, United States

Site Status

Des Peres, Missouri, United States

Site Status

Rochester, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Austin, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OTX-16-002

Identifier Type: -

Identifier Source: org_study_id

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