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
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Glaukos Corporation
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- change from baseline in mean diurnal IOP in the study eye
Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Travoprost Ophthalmic Topical Cream low-dose
Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days
Intervention: Travoprost Ophthalmic Topical Cream low-dose (Drug)
Travoprost Ophthalmic Topical Cream mid-dose
Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days
Intervention: Travoprost Ophthalmic Topical Cream mid-dose (Drug)
Travoprost Ophthalmic Topical Cream high-dose
Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days
Intervention: Travoprost Ophthalmic Topical Cream high-dose (Drug)
Timolol maleate ophthalmic solution, 0.5%
Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days
Intervention: Timolol maleate ophthalmic solution, 0.5% (Drug)
Travoprost ophthalmic solution, 0.004%
Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days
Intervention: Travoprost Ophthalmic Solution, 0.004% (Drug)
Outcomes
Primary Outcomes
change from baseline in mean diurnal IOP in the study eye
Time Frame: Day 29
Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye
Secondary Outcomes
No secondary outcomes reported