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

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

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%.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost Ophthalmic Topical Cream low-dose; Drug: Travoprost Ophthalmic Topical Cream mid-dose; Drug: Travoprost Ophthalmic Topical Cream high-dose; Drug: Timolol maleate ophthalmic solution, 0.5%; Drug: Travoprost Ophthalmic Solution, 0.004%

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Clinical Trial Associate; Phone Number: 949-367-9600; Email: SVea@glaukos.com
• Study Contact Backup: Name: Study Manager; Phone Number: 949-367-9600; Email: PBraswell@glaukos.com

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Glaukos Clinical Study Site
      • Contact: Glaukos Study Manager; Phone Number: 949-367-9600; Email: PBraswell@glaukos.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost Ophthalmic Topical Cream low-dose; Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days	Drug: Travoprost Ophthalmic Topical Cream low-dose; travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
Experimental: Travoprost Ophthalmic Topical Cream mid-dose; Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days	Drug: Travoprost Ophthalmic Topical Cream mid-dose; travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
Experimental: Travoprost Ophthalmic Topical Cream high-dose; Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days	Drug: Travoprost Ophthalmic Topical Cream high-dose; travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
Active Comparator: Timolol maleate ophthalmic solution, 0.5%; Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days	Drug: Timolol maleate ophthalmic solution, 0.5%; timolol maleate ophthalmic solution, 0.5% twice daily (morning & evening) to both eyes
Active Comparator: Travoprost ophthalmic solution, 0.004%; Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days	Drug: Travoprost Ophthalmic Solution, 0.004%; travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in mean diurnal IOP in the study eye	Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye	Day 29

Collaborators and Investigators

• Sponsor: Glaukos Corporation
• Investigators: Study Director: Study Director, Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: GLK-311-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No