Conditions: Ocular Hypertension Open Angle Glaucoma
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 19
Healthy volunteers: no

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).

Arms:
arm 1: 15 µg (formulation1) implant arm 2: 26 µg (formulation1) implant arm 3: 15 µg (formulation 2) implant arm 4: 5 µg (formulation 3) implant

Interventions: intervention 1: OTX-TIC
Intervention descriptions: intervention 1: OTX-TIC implant is injection in the anterior chamber of the eye

Protocol document:
Prot_000.pdf: 
A prospective, multi-center, open-label study to 
evaluate the safety, tolerability and efficacy of 
OTX-TIC (travoprost) intracameral implant in 
subjects with primary open-angle glaucoma 
(OAG) or ocular hypertension (OHT) 
NCT04360174 
July 28, 2020 












• Anterior segment (AS)-OCT 
• Automatic Visual Field 
 
 
 
Study Outcome 
Measure 
 
• Diurnal IOP (8 a.m., 10 a.m., 4 p.m.) will be checked at 
baseline, Day 14 (Visit 5), Day 42 (Visit 7), Day 85 (Visit 
8), Month 4 (Visit 9), and Month 6 (Visit 11). IOP will 
continue to be measured if biological activity is noted at 
Month 6. 
• Intraocular pressure (at 8 a.m. on the day of insertion; Days 
3, 7, and 28; and Month 5 [Visit 10]) 
Procedural Exclusion 
Criteria 
Unsuccessful intracameral injection (record reason for injection 
failure on the electronic Case Report Form, i.e., eCRF); in the case 
of injection failure do not attempt another injection. The study will 
be supplemented with additional subjects to account for these 
subjects in order to ensure that the necessary number of subjects 
receive the implant to inform on safety, tolerability and efficacy. 
 

SAP_001.pdf: 
A prospective, multi-center, open-label study to 
evaluate the safety, tolerability and efficacy of 
OTX-TIC (travoprost) intracameral implant in 
subjects with primary open-angle glaucoma 
(OAG) or ocular hypertension (OHT) 
NCT04360174 
July 28, 2020