Overview

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)

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ocular Therapeutix, Inc.
Treatments:
Bimatoprost
Travoprost
Criteria
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