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Travoprost Intraocular Implant + iStent Infinite

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment reduced: 230 → 150 participantsv3 Show 6 more changesShow less
    • Phase changed: Phase 3 → Phase 4
    • Trial arms changed: 3 → 2
    • Interventions: Sham procedure 1 (Other), Sham procedure 2 (Other), Travoprost Intraocular Implant (Drug), iStent infinite (Device) to Sham procedure (Other), Travoprost Intraocular Implant (Drug), iStent infinite (Device)
    • Site details revised
    • Eligibility criteria shortened, about 1 word
    • Study title shortened, about 4 words
  2. Enrollment target: 150 to 230v2 Show 5 more changesShow less
    • Primary completion date: Feb 2025 to May 2027
    • Study completion date: Nov 2025 to Feb 2028
    • Interventions: Sham procedure (Other), Travoprost Intraocular Implant (Drug), iStent infinite (Device) to Sham procedure 1 (Other), Sham procedure 2 (Other), Travoprost Intraocular Implant (Drug), iStent infinite (Device)
    • Site contact updated
    • Study arms: 2 to 3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06066645
Lead Sponsor Glaukos Corporation
Conditions
(from sponsor)		 Glaucoma, Open-Angle
Related terms Glaucoma, Open-Angle
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov