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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost Ophthalmic Topical Cream low-dose | Experimental | Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days |
|
| Travoprost Ophthalmic Topical Cream mid-dose | Experimental | Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days |
|
| Travoprost Ophthalmic Topical Cream high-dose | Experimental | Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days |
|
| Timolol maleate ophthalmic solution, 0.5% | Active Comparator | Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days |
|
| Travoprost ophthalmic solution, 0.004% | Active Comparator | Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost Ophthalmic Topical Cream low-dose | Drug | travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Clinical Trial Associate | Contact | 949-367-9600 | SVea@glaukos.com | |
| Study Manager | Contact | 949-367-9600 | PBraswell@glaukos.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Clinical Study Site | Recruiting | Newport Beach | California | 92663 | United States |
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| Travoprost Ophthalmic Topical Cream mid-dose | Drug | travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes |
|
| Travoprost Ophthalmic Topical Cream high-dose | Drug | travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes |
|
| Timolol maleate ophthalmic solution, 0.5% | Drug | timolol maleate ophthalmic solution, 0.5% twice daily (morning & evening) to both eyes |
|
| Travoprost Ophthalmic Solution, 0.004% | Drug | travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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