Status:
COMPLETED
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Open Angle Glaucoma and Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 oc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04061044
Start Date
July 10 2018
End Date
September 22 2020
Last Update
June 9 2023
Active Locations (1)
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1
ApexEye
Cincinnati, Ohio, United States, 45242