A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Phase 2

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: OTX-TIC low dose Travoprost Intracameral Implant; Drug: OTX-TIC high dose Travoprost Intracameral Implant; Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

• Registration Number: NCT05335122
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Detailed Description

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Study Timeline

• Study Start: 2022-03-16
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Primary Completion: 2024-01-24
• Study Completion: 2025-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Are 18 years of age or older at the time of screening
• Provide written informed consent and are able to comply with all study requirements
• Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
• Have a negative pregnancy test result for women of childbearing potential at Baseline
• Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria

• Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
• Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
• Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-TIC Low Dose	OTX-TIC low dose Travoprost Intracameral Implant	Travoprost Intracameral Implant low dose
OTX-TIC High Dose	OTX-TIC high dose Travoprost Intracameral Implant	Travoprost Intracameral Implant high dose
Durysta	Durysta, Bimatoprost Intracameral Implant 10 µg	Bimatoprost Intracameral Implant 10 µg

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome: IOP changes from Baseline	Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]	IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye

Trial Locations

Locations (4)

Ocular Therapeutiux, Inc.; 🇺🇸 Fargo, North Dakota, United States

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

Ocular Therapeutix Inc; 🇺🇸 Oklahoma City, Oklahoma, United States

Ocular Therapeutix Inc.; 🇺🇸 Saint Louis, Missouri, United States