Travoprost Intraocular Implant + iStent Infinite
Part of paid clinical trials in Oklahoma City, Oklahoma.
- Sponsor
- Glaukos Corporation
- Study ID
- NCT06066645
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Glaucoma, Open-Angle
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Travoprost Intraocular Implant — DRUGanchored intracameral implant containing travoprost
- iStent infinite — DEVICESuccessful iStent infinite surgery
- Sham procedure — OTHERSham procedure (to mimic placement of an iStent infinite)
Study Details
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
Key Dates
- Start date
- Sep 14, 2023
- Status verified
- May 2026
- Primary completion
- May 31, 2027
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: iDose TRTravoprost Intraocular Implant in subjects who had successful iStent infinite placement
- Active Comparator: iDose TR aloneTravoprost Intraocular Implant
Primary Outcome Measure
change from baseline in mean diurnal intraocular pressure (IOP) [ Time Frame: 3 months ]
Central Contacts
- Study Director949-739-8749
- Study Manager949-739-8749
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Glaukos Clinical Study Site | Oklahoma City | Oklahoma | 73112 |
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