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The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trav 0.00013% | Experimental | Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
|
| Trav 0.00033% | Experimental | Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
|
| Trav 0.001% | Experimental | Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
|
| Trav 0.00267% | Experimental | Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
|
| TRAVATAN | Active Comparator | Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost Ophthalmic Solution, 0.00013% | Drug | Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Area Under the Curve (AUC) in IOP Reduction | Day 5 |
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Inclusion Criteria:
Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
Must sign an informed consent form.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Walker, PhD | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Vehicle | Placebo Comparator | Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
|
| Travoprost Ophthalmic Solution, 0.00033% | Drug | Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose |
|
| Travoprost Ophthalmic Solution, 0.001% | Drug | Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose |
|
| Travoprost Ophthalmic Solution, 0.00267% | Drug | Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose |
|
| Travoprost Ophthalmic Solution, 0.004% | Drug |
|
|
| Travoprost Vehicle | Drug | Inactive ingredients used as an active comparator |
|
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |