Recruiting

Travoprost & iStent Infinite

Sponsor:

Glaukos Corporation

Code:

NCT06066645

Conditions

Glaucoma, Open-Angle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Travoprost Intraocular Implant

iStent infinite

Sham procedure

Study Details

Brief 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.

Conditions

Glaucoma, Open-Angle

Study ID

NCT06066645

Start date

Sep 14, 2023

Status verified date

May, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iDose TR

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

active comparator: iDose TR alone

Travoprost Intraocular Implant

Interventions

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)

Primary outcome measure

  • change from baseline in mean diurnal intraocular pressure (IOP) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Study Director

949-739-8749idoseclinical@glaukos.com

Study Manager

949-739-8749idoseclinical@glaukos.com

Locations

Glaukos Clinical Study Site

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

Study Director

949-739-8749idoseclinical@Glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-06-02.