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Clinical Trials in the USA / NCT06066645
Recruiting Phase 4

Travoprost Intraocular Implant + iStent Infinite

NCT06066645 · tracked via the Priya Life Science USA tracker
Sponsor
Glaukos Corporation
Phase
Phase 4
Started
2023-09-14
Last updated
2026-06-02

Condition(s) studied

Glaucoma, Open-Angle

Investigational drug(s) / intervention(s)

Travoprost Intraocular ImplantiStent infiniteSham procedure

Travoprost Intraocular Implant: anchored intracameral implant containing travoprost

iStent infinite: Successful iStent infinite surgery

Sham procedure: Sham procedure (to mimic placement of an iStent infinite)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * diagnosis of open-angle glaucoma or ocular hypertension * qualifying IOP in the study eye Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

  • change from baseline in mean diurnal intraocular pressure (IOP) — 3 months
    mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline

Trial sites (1)

FacilityCityRegionStatus
Glaukos Clinical Study Site Oklahoma City Oklahoma Recruiting

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Other trials for the same condition

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone Recruiting
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension Active, not recruiting
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06066645 on ClinicalTrials.gov ↗ ← All trials in the USA