Study of Exchange of Travoprost Intraocular Implant

Phase 2

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Drug: Travoprost

• Registration Number: NCT04615403
• Lead Sponsor: Glaukos Corporation

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.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Study Start: 2020-11-19
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Results First Submitted: 2023-07-21
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Results First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation and Exchange	Travoprost	Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.

Primary Outcome Measures

Name	Time	Method
Ocular Safety	12 Months	Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye

Trial Locations

Locations (14)

The Eye Associates of Manatee; 🇺🇸 Manatee, Florida, United States

North Bath Eye Associates, Inc.; 🇺🇸 Petaluma, California, United States

Center for Sight; 🇺🇸 Sarasota, Florida, United States

Oklahoma Eye Surgeons; 🇺🇸 Oklahoma City, Oklahoma, United States

Inland Eye Specialists; 🇺🇸 Hemet, California, United States

Ocala Eye; 🇺🇸 Ocala, Florida, United States

D'Ambrosio Eye Care; 🇺🇸 Lancaster, Massachusetts, United States

Jones Eye Clinic; 🇺🇸 Sioux City, Iowa, United States

Northern New Jersey Eye Institute; 🇺🇸 South Orange, New Jersey, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

Asian Eye Institute; 🇵🇭 Makati City, Philippines

Eye Center of northern Colorado, PC; 🇺🇸 Fort Collins, Colorado, United States

Lehmann Eye Center; 🇺🇸 Nacogdoches, Texas, United States