NCT06066645PHASE4Recruiting
Travoprost Intraocular Implant + iStent Infinite
Glaukos Corporation
Start Date
9/14/2023
Completion Date
2/1/2028
Summary
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
Eligibility Criteria
Age Range: 18 years to No maximum
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
* 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
Interventions
DRUG
Travoprost Intraocular Implant
DEVICE
iStent infinite
OTHER
Sham procedure
Conditions
Glaucoma, Open-Angle
Locations
Glaukos Clinical Study Site
Oklahoma City, Oklahoma 73112
United States