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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• diagnosis of open-angle glaucoma or ocular hypertension
• qualifying IOP in the study eye
Locations
United States
Colorado
Glaukos Clinical Study Site
RECRUITING
Colorado Springs
Contact Information
Primary
Study Director
idose@glaukos.com
949-481-8076
Backup
Study Manager
idose@glaukos.com
949-481-8076
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2025-11
Participants
Target number of participants: 150
Treatments
Experimental: iDose TR
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
Sham_comparator: sham procedure
Sham surgical procedure in subjects who had successful iStent infinite placement
Related Therapeutic Areas
Sponsors
Leads: Glaukos Corporation