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COMPLETEDPhase 3NCT02914509

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

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...

Lead sponsor: Ocular Therapeutix, Inc.•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Ocular Therapeutix, Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 11, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment565

Start dateNov 2016

Last updatedOct 11, 2021

Condition

Open Angle Glaucoma Ocular Hypertension

Locations shown

Artesia, California

Colorado Springs, Colorado

Lakeland, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2021Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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