CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: OTX-TIC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-TIC-Cohort 1<br>15 µg (formulation1) implant | Drug: OTX-TIC<br>* OTX-TIC implant is injection in the anterior chamber of the eye<br>|
| Experimental: OTX-TIC-Cohort 2<br>26 µg (formulation1) implant | Drug: OTX-TIC<br>* OTX-TIC implant is injection in the anterior chamber of the eye<br>|
| Experimental: OTX-TIC-Cohort 3<br>15 µg (formulation 2) implant | Drug: OTX-TIC<br>* OTX-TIC implant is injection in the anterior chamber of the eye<br>|
| Experimental: OTX-TIC-Cohort 4<br>5 µg (formulation 3) implant | Drug: OTX-TIC<br>* OTX-TIC implant is injection in the anterior chamber of the eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events for each subject | All adverse events will be captured throughout the study | Through study completion, 6 months | 
| Efficacy outcome | IOP measurements at 8 am, 10 am, and 4 pm | Diurnal IOP [Time Frame: 2 Week Visit] | 
| Efficacy outcome | IOP measurements at 8 am, 10 am, and 4 pm | Diurnal IOP [ 6 Week Visit] | 
| Efficacy outcome | IOP measurements at 8 am, 10 am, and 4 pm | Diurnal IOP [12 Week Visit] | 
| Efficacy outcome | IOP measurements at 8 am, 10 am, and 4 pm | Diurnal IOP [4 Months Visit] | 
| Efficacy outcome | IOP measurements at 8 am, 10 am, and 4 pm | Diurnal IOP [6 Months Visit] |