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The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost APS | Experimental | Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days |
|
| XALATAN | Active Comparator | Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost APS 40 micrograms/ml eye drop solution | Drug | non-BAK (benzalkonium chloride) medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90) | Day 90 |
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Inclusion Criteria:
Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.
Women of childbearing potential must meet all of the following conditions at Visit 1:
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Landry, Ph.D. | 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 |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Latanoprost 50 micrograms/ml eye drop solution | Drug | BAK-preserved medication |
|
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |