Recruiting
Travoprost Intraocular Implant + iStent Infinite
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.
ClinicalTrials.gov IDNCT06066645
PhasePHASE4
Enrollment150
SponsorGlaukos Corporation
Age18 Years
SexALL
Conditions studied
Glaucoma, Open-Angle
About this study
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.
Interventions
- Drug: Travoprost Intraocular Implant — anchored intracameral implant containing travoprost
- Device: iStent infinite — Successful iStent infinite surgery
- Other: Sham procedure — Sham procedure (to mimic placement of an iStent infinite)
Primary outcomes
- change from baseline in mean diurnal intraocular pressure (IOP) (3 months)
Eligibility information
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
Study locations
- Glaukos Clinical Study Site, Oklahoma City, Oklahoma 73112 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.