RECRUITING

Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension

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

The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.

Official Title

Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension

Quick Facts

Study Start:2023-11-15
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06152861

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. * Male or female, 18 years of age or older at the Screening Visit;
  2. * Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
  3. * Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
  4. * Qualifying IOP in the study eye;
  5. * Best-corrected visual acuity of approximately 20/80 Snellen in each eye
  1. * Sensitivity or allergy to travoprost or timolol;
  2. * Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
  3. * History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
  4. * History of cerebrovascular insufficiency;
  5. * Any form of glaucoma other than open-angle glaucoma
  6. * Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
  7. * Non-qualifying prior surgeries or procedures in either eye

Contacts and Locations

Study Contact

Study Clinical Trial Associate
CONTACT
949-367-9600
SVea@glaukos.com
Study Manager
CONTACT
949-367-9600
PBraswell@glaukos.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Glaukos Corporation

Study Locations (Sites)

Glaukos Clinical Study Site
Newport Beach, California, 92663
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 Date2023-11-15
Study Completion Date2024-08

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

  • Open Angle Glaucoma
  • Ocular Hypertension