Travoprost Intraocular Implant + iStent Infinite

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 in Subjects With Open-angle Glaucoma or Ocular Hypertension

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.

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