Clincosm LogoSign in Get a demo

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Sponsor
Glaukos Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06066645
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
25.6
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Travoprost Intraocular Implant
  • Other: Sham procedure
  • Device: iStent infinite
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 14, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: iDose TR

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Drug: Travoprost Intraocular Implant
anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite
Other Names:
  • iDose TR

    • Device: iStent infinite
    Successful iStent infinite surgery
    Sham Comparator: sham procedure

    Sham surgical procedure in subjects who had successful iStent infinite placement

    Other: Sham procedure
    Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

    Device: iStent infinite
    Successful iStent infinite surgery

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glaukos Clinical Study Site Colorado Springs Colorado United States 80907

    Sponsors and Collaborators

    • Glaukos Corporation

    Investigators

    • Study Director: Study Director, Glaukos Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Glaukos Corporation
    ClinicalTrials.gov Identifier:
    NCT06066645
    Other Study ID Numbers:
    • GLK-101-01
    First Posted:
    Oct 4, 2023
    Last Update Posted:
    Oct 4, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Travoprost

    Study Results

    No Results Posted as of Oct 4, 2023