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

Ocular Therapeutix

Status and phase: Completed; Phase 1

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: OTX-TIC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04360174

CLN-Protocol-0045

Details and patient eligibility

About

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.

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 4 patient groups

OTX-TIC-Cohort 1

Experimental group

Description:

15 µg (formulation1) implant

Treatment:

Drug: OTX-TIC

OTX-TIC-Cohort 2

Experimental group

Description:

26 µg (formulation1) implant

Treatment:

Drug: OTX-TIC

OTX-TIC-Cohort 3

Experimental group

Description:

15 µg (formulation 2) implant

Treatment:

Drug: OTX-TIC

OTX-TIC-Cohort 4

Experimental group

Description:

5 µg (formulation 3) implant

Treatment:

Drug: OTX-TIC