Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
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
1 other identifier
interventional
565
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedResults Posted
Study results publicly available
October 11, 2021
CompletedOctober 11, 2021
September 1, 2021
2.4 years
September 21, 2016
April 29, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Mean IOP
Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Mean IOP
Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Mean IOP
Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
Other Outcomes (1)
Number of Participants With Serious Adverse Events
Through study completion, an average of 23 months
Study Arms (2)
OTX-TP (sustained release travoprost) Intracanalicular Depot
EXPERIMENTALOTX-TP (sustained release travoprost) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot
PLACEBO COMPARATORPV (Placebo Vehicle) Intracanalicular Depot
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Artesia, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Lakeland, Florida, United States
Unknown Facility
Morrow, Georgia, United States
Unknown Facility
Shawnee Mission, Kansas, United States
Unknown Facility
Des Peres, Missouri, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Austin, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Ocular Therapeutix, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 26, 2016
Study Start
November 7, 2016
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
October 11, 2021
Results First Posted
October 11, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share