Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02914509 |
Recruitment Status :
Completed
First Posted : September 26, 2016
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Open Angle Glaucoma Ocular Hypertension | Drug: Travoprost Other: Placebo Vehicle | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 565 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 7, 2016 |
Actual Primary Completion Date : | March 30, 2019 |
Actual Study Completion Date : | March 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: OTX-TP (sustained release travoprost) Intracanalicular Depot
OTX-TP (sustained release travoprost) Intracanalicular Depot
|
Drug: Travoprost |
Placebo Comparator: PV (Placebo Vehicle) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot
|
Other: Placebo Vehicle |
- Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit ]
- Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit ]
- Mean IOP [ Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit ]
- Number of Participants With Serious Adverse Events [ Time Frame: Through study completion, an average of 23 months ]Number of Participants with Serious Adverse Events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914509
United States, California | |
Artesia, California, United States | |
United States, Colorado | |
Colorado Springs, Colorado, United States | |
United States, Florida | |
Lakeland, Florida, United States | |
United States, Georgia | |
Morrow, Georgia, United States | |
United States, Kansas | |
Shawnee Mission, Kansas, United States | |
United States, Missouri | |
Des Peres, Missouri, United States | |
United States, New York | |
Rochester, New York, United States | |
United States, North Carolina | |
Raleigh, North Carolina, United States | |
United States, Ohio | |
Cincinnati, Ohio, United States | |
United States, Texas | |
Austin, Texas, United States |
Documents provided by Ocular Therapeutix, Inc.:
Responsible Party: | Ocular Therapeutix, Inc. |
ClinicalTrials.gov Identifier: | NCT02914509 |
Other Study ID Numbers: |
OTX-16-002 |
First Posted: | September 26, 2016 Key Record Dates |
Results First Posted: | October 11, 2021 |
Last Update Posted: | October 11, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Travoprost Antihypertensive Agents |