Open Angle Glaucoma and Ocular Hypertension
Conditions
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.
Interventions
DRUGOphthalmic Insert
Travoprost, 0.32 mg
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Related Adverse Events (Safety and Tolerability) | 12 months |
Countries
United States
Outcome results
None listed