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

Study Overview
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Brief Summary
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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%.

Official Title
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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

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* 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%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost Ophthalmic Topical Cream low-dose<br>Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days | Drug: Travoprost Ophthalmic Topical Cream low-dose<br>* travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes<br>|
| Experimental: Travoprost Ophthalmic Topical Cream mid-dose<br>Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days | Drug: Travoprost Ophthalmic Topical Cream mid-dose<br>* travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes<br>|
| Experimental: Travoprost Ophthalmic Topical Cream high-dose<br>Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days | Drug: Travoprost Ophthalmic Topical Cream high-dose<br>* travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes<br>|
| Active Comparator: Timolol maleate ophthalmic solution, 0.5%<br>Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days | Drug: Timolol maleate ophthalmic solution, 0.5%<br>* timolol maleate ophthalmic solution, 0.5% twice daily (morning & evening) to both eyes<br>|
| Active Comparator: Travoprost ophthalmic solution, 0.004%<br>Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days | Drug: Travoprost Ophthalmic Solution, 0.004%<br>* travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |