RECRUITINGPhase 3INTERVENTIONAL

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

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 vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension

About This Trial

Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosis of open-angle glaucoma or ocular hypertension - qualifying IOP in the study eye Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Travoprost Intraocular Implant

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

OTHER

Sham procedure 1

Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

DEVICE

iStent infinite

Successful iStent infinite surgery

OTHER

Sham procedure 2

Sham procedure (to mimic placement of an iStent infinite)

Locations (1)

Glaukos Clinical Study Site

Colorado Springs, Colorado, United States