Study of Exchange of Travoprost Intraocular Implant

Completed · Phase 2

Conditions studied: Open Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT04615403

Run by

Glaukos Corporation

People needed

33

Starts

2020-11-19

Expected to finish

2022-02-28

Last updated by the study team

2023-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Inland Eye Specialists — Hemet, California, United States
• North Bath Eye Associates, Inc. — Petaluma, California, United States
• Eye Center of northern Colorado, PC — Fort Collins, Colorado, United States
• The Eye Associates of Manatee — Manatee, Florida, United States
• Ocala Eye — Ocala, Florida, United States
• Center for Sight — Sarasota, Florida, United States
• Jones Eye Clinic — Sioux City, Iowa, United States
• D'Ambrosio Eye Care — Lancaster, Massachusetts, United States
• Northern New Jersey Eye Institute — South Orange, New Jersey, United States
• Oklahoma Eye Surgeons — Oklahoma City, Oklahoma, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Texan Eye — Austin, Texas, United States
• Lehmann Eye Center — Nacogdoches, Texas, United States
• Asian Eye Institute — Makati City, Philippines

Full record on ClinicalTrials.gov

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