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

Phase 2

Recruiting

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

• Registration Number: NCT06152861
• Lead Sponsor: Glaukos Corporation

Brief 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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-15
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost Ophthalmic Topical Cream low-dose	Travoprost Ophthalmic Topical Cream low-dose	Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days
Travoprost ophthalmic solution, 0.004%	Travoprost Ophthalmic Solution, 0.004%	Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days
Timolol maleate ophthalmic solution, 0.5%	Timolol maleate ophthalmic solution, 0.5%	Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days
Travoprost Ophthalmic Topical Cream mid-dose	Travoprost Ophthalmic Topical Cream mid-dose	Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days
Travoprost Ophthalmic Topical Cream high-dose	Travoprost Ophthalmic Topical Cream high-dose	Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days

Primary Outcome Measures

Name	Time	Method
change from baseline in mean diurnal IOP in the study eye	Day 29	Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye

Trial Locations

Locations (1)

Glaukos Clinical Study Site; 🇺🇸 Newport Beach, California, United States