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Recruiting

NCT Number: NCT06066645

Travoprost Intraocular Implant + iStent Infinite

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.

Recruiting

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaukos Clinical Study Site

Oklahoma City, Oklahoma, 73112, United States

Location status: Recruiting

Location contact

Study Director

CONTACT

[email protected]

949-739-8749

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Travoprost Intraocular Implant

Drug

anchored intracameral implant containing travoprost

Other names: iDose TR

iStent Infinite

Device

Successful iStent infinite surgery

Sham Procedure

Other

Sham procedure (to mimic placement of an iStent infinite)

Primary outcomes

  1. change from baseline in mean diurnal intraocular pressure (IOP)

    Time frame: 3 months

    mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

949-739-8749

Study Manager

CONTACT

[email protected]

949-739-8749

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study 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 in Subjects With Open-angle Glaucoma or Ocular Hypertension

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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