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OTX-TP

Phase 2

Glaucoma | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Dec 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

OTX-TP · 1 trial · 2 indications

Phase 2 1
NCT02312544Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular HypertensionGlaucoma
COMPLETED72 Analytics
PHASE2COMPLETED
Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit
Days 57 to 63
Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit
Days 87 to 93
Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and Days 87 to 93
Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and Days 87 to 93
Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and 87 to 93
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OTX-TP treatmentACTIVE_COMPARATOROTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately
Timolol controlACTIVE_COMPARATORTimolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV).

Interventions

NameTypeDescription
OTX-TPDRUGOTX-TP and placebo drops
TimololDRUGTimolol drops and placebo punctum plug
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component). * Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of ≥ 24mmHg at Hour 0 (T0) at Basel...

Countries:United States
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Frequently asked questions about OTX-TP

What is OTX-TP used for in glaucoma?

OTX-TP is an investigational small molecule being developed for the treatment of glaucoma. It is designed to be administered as an intracanalicular insert for sustained drug delivery. In clinical trials, it has been evaluated in patients with open angle glaucoma or ocular hypertension.

What does OTX-TP target?

OTX-TP is a small molecule formulation of travoprost, a prostaglandin analog that lowers intraocular pressure by increasing aqueous humor outflow. It is being developed as a sustained-release intracanalicular insert for the treatment of glaucoma and ocular hypertension.

Who makes OTX-TP?

OTX-TP is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol OCUL. The company is focused on ophthalmic therapies.

What phase is OTX-TP in?

OTX-TP is in Phase 2 clinical development. A Phase 2b study has been completed, evaluating its safety and efficacy compared to timolol eye drops in patients with open angle glaucoma or ocular hypertension.

What clinical trials is OTX-TP in?

OTX-TP has been studied in one completed Phase 2b clinical trial, NCT02312544. This randomized, double-blind, active-controlled study enrolled 72 participants in the United States and compared OTX-TP to timolol drops in patients with open angle glaucoma or ocular hypertension.

Is OTX-TP the same as travoprost?

OTX-TP is a proprietary formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. While travoprost is the active pharmaceutical ingredient, OTX-TP is a sustained-release intracanalicular insert designed to deliver the drug over an extended period.