RECRUITING

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Description

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.

Conditions

Glaucoma, Open-Angle
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Related Conditions:

Glaucoma, Open-Angle

Study Overview

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Study Details

Study overview

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.

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

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Condition
Glaucoma, Open-Angle
Intervention / Treatment

-

Contacts and Locations

Colorado Springs

Glaukos Clinical Study Site, Colorado Springs, Colorado, United States, 80907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * diagnosis of open-angle glaucoma or ocular hypertension
  • * qualifying IOP in the study eye
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Glaukos Corporation,

Study Director, STUDY_DIRECTOR, Glaukos Corporation

Study Record Dates

2025-11