NCT04615403

Study of Exchange of Travoprost Intraocular Implant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Travoprost	Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision

Timeline

• Start date: 2020-11-19
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2020-11-04
• Last updated: 2023-09-26
• Results posted: 2023-09-26

Locations

14 sites across 2 countries: United States, Philippines

Regulatory

• FDA-regulated drug study