Back to resultsPhase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Travoprost
Placebo Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OTX-TP (sustained release travoprost) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot
Arm Description
OTX-TP (sustained release travoprost) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot
Outcomes
Primary Outcome Measures
Mean IOP
Mean IOP
Mean IOP
Secondary Outcome Measures
Full Information
NCT ID
NCT02914509
First Posted
September 21, 2016
Last Updated
September 14, 2021
Sponsor
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02914509
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
565 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTX-TP (sustained release travoprost) Intracanalicular Depot
Arm Type
Experimental
Arm Description
OTX-TP (sustained release travoprost) Intracanalicular Depot
Arm Title
PV (Placebo Vehicle) Intracanalicular Depot
Arm Type
Placebo Comparator
Arm Description
PV (Placebo Vehicle) Intracanalicular Depot
Intervention Type
Drug
Intervention Name(s)
Travoprost
Intervention Type
Other
Intervention Name(s)
Placebo Vehicle
Primary Outcome Measure Information:
Title
Mean IOP
Time Frame
Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
Title
Mean IOP
Time Frame
Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
Title
Mean IOP
Time Frame
Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
Other Pre-specified Outcome Measures:
Title
Number of Participants With Serious Adverse Events
Description
Number of Participants with Serious Adverse Events
Time Frame
Through study completion, an average of 23 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
Morrow
State/Province
Georgia
Country
United States
City
Shawnee Mission
State/Province
Kansas
Country
United States
City
Des Peres
State/Province
Missouri
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
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