A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Ocular Treatment Emergent Adverse Events
Study Overview
Brief Summary
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed Description
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
- •Have IOP that is currently controlled as assessed by the Investigator
- •Have open, normal appearing anterior chamber angles as determined by gonioscopy
Exclusion Criteria
- •Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
- •Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
Arms & Interventions
OTX-TIC-Cohort 1
15 µg (formulation1) implant
Intervention: OTX-TIC (Drug)
OTX-TIC-Cohort 2
26 µg (formulation1) implant
Intervention: OTX-TIC (Drug)
OTX-TIC-Cohort 3
15 µg (formulation 2) implant
Intervention: OTX-TIC (Drug)
OTX-TIC-Cohort 4
5 µg (formulation 3) implant
Intervention: OTX-TIC (Drug)
Outcomes
Primary Outcomes
Ocular Treatment Emergent Adverse Events
Time Frame: Through study completion, 6 months
All adverse events will be captured throughout the study
Efficacy Outcome
Time Frame: Diurnal IOP [12 Week Visit]
IOP measurements at 8 am
Secondary Outcomes
No secondary outcomes reported