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)

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: OTX-TIC high dose Travoprost Intracameral Implant; Drug: Durysta, Bimatoprost Intracameral Implant 10 µg; Drug: OTX-TIC low dose Travoprost Intracameral Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05335122

OTX-TIC-2020-201

Details and patient eligibility

About

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)

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 3 patient groups

OTX-TIC Low Dose

Experimental group

Description:

Travoprost Intracameral Implant low dose

Treatment:

Drug: OTX-TIC low dose Travoprost Intracameral Implant

OTX-TIC High Dose

Experimental group

Description:

Travoprost Intracameral Implant high dose

Treatment:

Drug: OTX-TIC high dose Travoprost Intracameral Implant

Durysta

Active Comparator group

Description:

Bimatoprost Intracameral Implant 10 µg

Treatment:

Drug: Durysta, Bimatoprost Intracameral Implant 10 µg