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
  • End date
    Jul 29, 2023
  • participants needed
    105
  • sponsor
    Ocular Therapeutix, Inc.
Updated on 29 April 2022
hypertension
glaucoma
bimatoprost
travoprost

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)

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.

Details
Condition Open Angle Glaucoma, Ocular Hypertension
Treatment OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 µg
Clinical Study IdentifierNCT05335122
SponsorOcular Therapeutix, Inc.
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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
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