Status:
COMPLETED
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Ocular Hypertension
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hyper...
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 hypertens...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04360174
Start Date
April 25 2018
End Date
May 24 2021
Last Update
October 1 2024
Active Locations (5)
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1
Ocular Therapeutix, Inc.
Petaluma, California, United States, 94954
2
Ocular Therapeutix, Inc.
Torrance, California, United States, 90505
3
Ocular Therapeutix, Inc
Roswell, Georgia, United States, 30076
4
Ocular Therapeutix, Inc.
Austin, Texas, United States, 78731