RecruitingPhase 3NCT06066645

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension


Sponsor

Glaukos Corporation

Enrollment

230 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two treatments for reducing eye pressure in people with glaucoma or ocular hypertension (elevated eye pressure that can damage vision). It tests adding a travoprost intraocular implant (a tiny drug-releasing device placed in the eye) to a procedure called iStent Infinite, versus iStent Infinite alone. **You may be eligible if...** - You have been diagnosed with open-angle glaucoma or ocular hypertension - Your eye pressure qualifies for the study based on screening measurements **You may NOT be eligible if...** - Your unmedicated eye pressure exceeds 36 mmHg - You are allergic to travoprost or any components of the implant - You have a severe visual field loss or a large optic nerve cup-to-disc ratio (>0.8) - Your best corrected vision is worse than 20/80 in either eye - You have another eye disease that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTravoprost Intraocular Implant

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

OTHERSham procedure 1

Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

DEVICEiStent infinite

Successful iStent infinite surgery

OTHERSham procedure 2

Sham procedure (to mimic placement of an iStent infinite)


Locations(1)

Glaukos Clinical Study Site

Colorado Springs, Colorado, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06066645


Related Trials