RECRUITING

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-09-14
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06066645

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of open-angle glaucoma or ocular hypertension
  2. * qualifying IOP in the study eye
  1. * unmedicated (washed out) IOP of \>36 mmHg in the study eye
  2. * hypersensitivity to travoprost or any other components of the travoprost intraocular implant
  3. * vertical cup/disc ratio \> 0.8 in the study eye
  4. * best spectacle corrected visual acuity of worse than 20/80 in either eye eye
  5. * 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

Study Contact

Study Director
CONTACT
949-481-8076
idose@glaukos.com
Study Manager
CONTACT
949-481-8076
idose@glaukos.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Glaukos Corporation

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Glaukos Corporation

  • Study Director, STUDY_DIRECTOR, Glaukos Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-14
Study Completion Date2025-11

Study Record Updates

Study Start Date2023-09-14
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Glaucoma, Open-Angle