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

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%.

Conditions

Open Angle Glaucoma, Ocular Hypertension

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Study Overview

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Study Details

Study overview

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%.

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

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

Condition
Open Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Glaukos Clinical Study Site, Newport Beach, California, United States, 92663

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

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

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

2024-08