Study of Exchange of Travoprost Intraocular Implant

Glaukos Corporation33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open Angle Glaucoma

Interventions

TravoprostDRUG

Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

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

Outcomes

Primary Outcomes

Ocular Safety

Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye

Time frame: 12 Months

Data from ClinicalTrials.gov

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