Clinical trial NCT04615403: Study of Exchange of Travoprost Intraocular Implant
Official title: Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ocular Safety
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Petaluma
country: United States
facility: North Bath Eye Associates, Inc.
state: California
city: Fort Collins
country: United States
facility: Eye Center of northern Colorado, PC
state: Colorado
city: Manatee
country: United States
facility: The Eye Associates of Manatee
state: Florida
city: Ocala
country: United States
facility: Ocala Eye
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Lancaster
country: United States
facility: D'Ambrosio Eye Care
state: Massachusetts
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons
state: Oklahoma
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
References: