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

Last updated: November 30, 2023
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Glaucoma

Ocular Hypertension

Circulation Disorders

Treatment

Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream high-dose

Timolol maleate ophthalmic solution, 0.5%

Clinical Study ID

NCT06152861
GLK-311-01
  • Ages > 18
  • All Genders

Study Summary

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%.

Eligibility Criteria

Inclusion

Inclusion 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 informedconsent 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

Exclusion

Exclusion Criteria:

  • Sensitivity or allergy to travoprost or timolol;
  • Bronchial asthma, a history of bronchial asthma, or severe chronic obstructivepulmonary disease;
  • History of or current sinus bradycardia, second- or third-degree atrioventricularblock, 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

Study Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Travoprost Ophthalmic Topical Cream mid-dose
Phase: 2
Study Start date:
November 15, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Glaukos Clinical Study Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

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