Clinical trial NCT02914509: Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean IOP
timeFrame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
measure: Mean IOP
timeFrame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
measure: Mean IOP
timeFrame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: Through study completion, an average of 23 months
Locations:
city: Artesia
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lakeland
country: United States
state: Florida
city: Morrow
country: United States
state: Georgia
city: Shawnee Mission
country: United States
state: Kansas
city: Des Peres
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Austin
country: United States
state: Texas
Study officials:
References: