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

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Other: Placebo Vehicle; Drug: Travoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914509

OTX-16-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 565 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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565 participants in 2 patient groups, including a placebo group

OTX-TP (sustained release travoprost) Intracanalicular Depot

Experimental group

Description:

OTX-TP (sustained release travoprost) Intracanalicular Depot

Treatment:

Drug: Travoprost

PV (Placebo Vehicle) Intracanalicular Depot

Placebo Comparator group

Description:

PV (Placebo Vehicle) Intracanalicular Depot

Treatment:

Other: Placebo Vehicle