Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant

IDOS-106-EXCH

The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.

2020-11-19

2022-02-28

2022-02-28

Completed

Early phase I

33

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

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2023-09-26