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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152861
• Other study ID #: GLK-311-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Glaukos Corporation
• Contact: Study Clinical Trial Associate
• Phone: 949-367-9600
• Email: SVea[@]glaukos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Travoprost Ophthalmic Topical Cream low-dose
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
• Travoprost Ophthalmic Topical Cream mid-dose
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
• Travoprost Ophthalmic Topical Cream high-dose
travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
• Timolol maleate ophthalmic solution, 0.5%
timolol maleate ophthalmic solution, 0.5% twice daily (morning & evening) to both eyes
• Travoprost Ophthalmic Solution, 0.004%
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes

Locations

Country	Name	City	State
United States	Glaukos Clinical Study Site	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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