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

Phase 1

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: OTX-TIC

• Registration Number: NCT04360174
• Lead Sponsor: Ocular Therapeutix, Inc.

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 Timeline

• Study Start: 2018-04-25
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-24
• Results First Submitted: 2023-05-23
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Results First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OTX-TIC-Cohort 1	OTX-TIC	15 µg (formulation1) implant
OTX-TIC-Cohort 2	OTX-TIC	26 µg (formulation1) implant
OTX-TIC-Cohort 4	OTX-TIC	5 µg (formulation 3) implant
OTX-TIC-Cohort 3	OTX-TIC	15 µg (formulation 2) implant

Primary Outcome Measures

Name	Time	Method
Ocular Treatment Emergent Adverse Events	Through study completion, 6 months	All adverse events will be captured throughout the study
Efficacy Outcome	Diurnal IOP [12 Week Visit]	IOP measurements at 8 am

Trial Locations

Locations (2)

Ocular Therapeutix, Inc.; 🇺🇸 Racine, Wisconsin, United States

Ocular Therapeutix, Inc; 🇺🇸 Roswell, Georgia, United States