Status:
UNKNOWN
Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
Lead Sponsor:
Glaukos Corporation
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06066645
Start Date
September 14 2023
End Date
November 1 2025
Last Update
October 4 2023
Active Locations (1)
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1
Glaukos Clinical Study Site
Colorado Springs, Colorado, United States, 80907