Back to resultsA Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Primary Purpose
Open Angle Glaucoma and Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ophthalmic Insert
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma and Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
- Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
- Have provided written informed consent, approved by the appropriate Institutional Review Board
Exclusion Criteria:
- Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
- Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
- Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
- Missed more than 2 visits during participation in the OTX-16-002 trial
Sites / Locations
- ApexEye
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04061044
Brief Title
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Official Title
A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the long term safety of repeat dose 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma and Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ophthalmic Insert
Other Intervention Name(s)
OTX-TP
Intervention Description
Travoprost, 0.32 mg
Primary Outcome Measure Information:
Title
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
Have provided written informed consent, approved by the appropriate Institutional Review Board
Exclusion Criteria:
Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
Missed more than 2 visits during participation in the OTX-16-002 trial
Facility Information:
Facility Name
ApexEye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
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