Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Launched by GLAUKOS CORPORATION · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new treatment for people with glaucoma, specifically those who have already received a device called the iStent Infinite to help lower eye pressure. The trial compares a travoprost intraocular implant, which releases medication to help reduce eye pressure, with a sham procedure, which means participants would not receive the active treatment but would still be part of the study. The goal is to see if adding the travoprost implant can further lower eye pressure compared to just having the iStent.

To be eligible for this trial, participants need to be adults diagnosed with open-angle glaucoma or ocular hypertension, which means they have higher-than-normal pressure in their eyes. However, individuals with very high eye pressure before treatment or certain eye conditions may not qualify. Participants will be randomly assigned to receive either the implant or the sham procedure and will be followed for 12 months to see how well their eye pressure is managed. This trial is currently recruiting participants aged 65 to 74, and both men and women can take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of open-angle glaucoma or ocular hypertension
• • qualifying IOP in the study eye
• Exclusion Criteria:
• • unmedicated (washed out) IOP of \>36 mmHg in the study eye
• • hypersensitivity to travoprost or any other components of the travoprost intraocular implant
• • vertical cup/disc ratio \> 0.8 in the study eye
• • best spectacle corrected visual acuity of worse than 20/80 in either eye eye
• • any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study