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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

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Conditions

Glaucoma, Open-Angle

Locations

Glaukos Clinical Study Site

Oklahoma City, Oklahoma 73112

United States