Phase 2 Trial Evaluating Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension

Sponsor

Glaukos Corporation (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152861

Collaborator

(none)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	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%	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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