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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914509
• Other study ID #: OTX-16-002
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: September 2021
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Travoprost

Other:
• Placebo Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Serious Adverse Events	Number of Participants with Serious Adverse Events	Through study completion, an average of 23 months
Primary	Mean IOP		Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Primary	Mean IOP		Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Primary	Mean IOP		Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit