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
Glaukos Corporation
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTravoprost Intraocular Implant
anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite
- OtherSham procedure 1
Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite
- DeviceiStent infinite
Successful iStent infinite surgery
- OtherSham procedure 2
Sham procedure (to mimic placement of an iStent infinite)
Location
- Glaukos Clinical Study SiteColorado Springs, Colorado