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 — DRUG
    anchored intracameral implant containing travoprost
  • iStent infinite — DEVICE
    Successful iStent infinite surgery
  • Sham procedure — OTHER
    Sham 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 TR
    Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
  • Active Comparator: iDose TR alone
    Travoprost Intraocular Implant

Primary Outcome Measure

change from baseline in mean diurnal intraocular pressure (IOP) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Glaukos Clinical Study SiteOklahoma CityOklahoma73112
Study Director
949-739-8749

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