Study of Exchange of Travoprost Intraocular Implant

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615403
• Other study ID #: IDOS-106-EXCH
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2023
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

United States,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Safety	Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye	12 Months