Study of Exchange of Travoprost Intraocular Implant

This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.

Inclusion criteria

• Able and willing to attend scheduled follow-up exams for the duration of the study
• Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
• Best spectacle corrected visual acuity of 20/80 or better in each eye.
• Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

Exclusion criteria

• Glaucoma status as follows:

• Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
• Corneal status as follows:

• Any active inflammation or edema
• Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
• Implantation of Travoprost Intraocular Implant
• Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
• Fellow eye status as follows:

• Fellow eye actively enrolled in this trial or any other clinical trial
• Subject status as follows:

• Pregnant or planning to become pregnant during the course of the study