A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Phase 3
Completed
- Conditions
- Open Angle Glaucoma and Ocular Hypertension
- Interventions
- Drug: Ophthalmic Insert
- Registration Number
- NCT04061044
- Lead Sponsor
- Ocular Therapeutix, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Ophthalmic Insert -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Related Adverse Events (Safety and Tolerability) 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ApexEye
🇺🇸Cincinnati, Ohio, United States