Travoprost Intraocular Implant + iStent Infinite

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Glaukos Corporation
Sponsor
Glaukos Corporation
Information Provided by (Responsible Party)
Glaukos Corporation
Clinicaltrials.gov Identifier
NCT06066645
Other Study ID Numbers:
GLK-101-01
First Submitted
September 26, 2023
First Posted
October 3, 2023
Last Update Posted
June 1, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Glaucoma, Open-Angle
Drug: Travoprost Intraocular ImplantDrug: Travoprost Intraocular Implant

Study Design

Study TypeInterventional
Actual Enrollment150 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleMulticenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension
Study Start DateSeptember 13, 2023
Actual Primary Completion Date9mos 2w from now
Actual Study Completion Date1yr 6mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
iDose TR
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
Drug: Travoprost Intraocular Implant
anchored intracameral implant containing travoprost
iDose TR alone
Travoprost Intraocular Implant
Drug: Travoprost Intraocular Implant
anchored intracameral implant containing travoprost

Outcome Measures

Primary Outcome Measures
  1. change from baseline in mean diurnal intraocular pressure (IOP)
    mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsGlaukos Corporation
Locations
Glaukos Clinical Study Site | Oklahoma City Oklahoma, United States, 73112
Investigators
Study Director: Study Director, Glaukos Corporation