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

Glaukos

Status and phase: Enrolling; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost Ophthalmic Topical Cream high-dose; Drug: Travoprost Ophthalmic Topical Cream mid-dose; Drug: Travoprost Ophthalmic Solution, 0.004%; Drug: Travoprost Ophthalmic Topical Cream low-dose; Drug: Timolol maleate ophthalmic solution, 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06152861

GLK-311-01

Details and patient eligibility

About

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%.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups

Travoprost Ophthalmic Topical Cream low-dose

Experimental group

Description:

Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days

Treatment:

Drug: Travoprost Ophthalmic Topical Cream low-dose

Travoprost Ophthalmic Topical Cream mid-dose

Experimental group

Description:

Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days

Treatment:

Drug: Travoprost Ophthalmic Topical Cream mid-dose

Travoprost Ophthalmic Topical Cream high-dose

Experimental group

Description:

Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days

Treatment:

Drug: Travoprost Ophthalmic Topical Cream high-dose

Timolol maleate ophthalmic solution, 0.5%

Active Comparator group

Description:

Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days

Treatment:

Drug: Timolol maleate ophthalmic solution, 0.5%

Travoprost ophthalmic solution, 0.004%

Active Comparator group

Description:

Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.004%