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

Phase 3

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Other: Placebo Vehicle; Drug: Travoprost

• Registration Number: NCT02914509
• Lead Sponsor: Ocular Therapeutix, Inc.

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

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 Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-26
• Study Start: 2016-11-07
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Results First Submitted: 2021-04-29
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Results First Posted: 2021-10-11
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV (Placebo Vehicle) Intracanalicular Depot	Placebo Vehicle	PV (Placebo Vehicle) Intracanalicular Depot
OTX-TP (sustained release travoprost) Intracanalicular Depot	Travoprost	OTX-TP (sustained release travoprost) Intracanalicular Depot

Primary Outcome Measures

Name	Time	Method
Mean IOP	Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit