Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Recruitment Status: RECRUITING
(See Contacts and Locations)Verified December 2025 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: January 20, 2026
Last Verified: December 2025

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

History of Changes

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Glaucoma, Open-Angle	Drug: Travoprost Intraocular ImplantOther: Sham procedure 1Drug: Travoprost Intraocular Implant

Study Design

Study Type	Interventional
Actual Enrollment	230 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
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
Study Start Date	September 13, 2023
Actual Primary Completion Date	11mos 1w from now
Actual Study Completion Date	1yr 8mos from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
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
sham procedure Sham surgical procedure	Other: Sham procedure 1 Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite
iDose TR alone Travoprost Intraocular Implant	Drug: Travoprost Intraocular Implant anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

Outcome Measures

Primary Outcome Measures

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 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

Sponsors and Collaborators	Glaukos Corporation
Locations	Glaukos Clinical Study Site \| Colorado Springs Colorado, United States, 80907
Investigators	Study Director: Study Director, Glaukos Corporation

More Information

Additional Relevant MeSH Terms

Glaucoma, Open-AngleGlaucomaOcular HypertensionEye Diseases