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
Glaukos Corporation
230 participants
Sep 14, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
Exclusion Criteria5
- 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
Interventions
anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite
Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite
Successful iStent infinite surgery
Sham procedure (to mimic placement of an iStent infinite)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06066645