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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xalatan® | Active Comparator |
| |
| Travatan Z® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalatan | Drug | 0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OSDI scores (patient's subjective assessment) | Eight Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Biomicroscopic changes as assessed by Masked Investigator | Eight Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marguerite McDonald, M.D. | Ophthalmic Consultants of Long Island | Principal Investigator |
| Barbara Burger, R.N. | Ophthalmic Consultans of Long Island | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Long Island | East Meadow | New York | 11554 | United States | ||
| Ophthalmic Consultants of Long Island |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2018 | |
| Reset | Sep 17, 2018 |
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| Travatan Z | Drug | 0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m. |
|
|
| Lynbrook |
| New York |
| 11563 |
| United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Ophthalmic Consultants of Long Island | Stony Brook | New York | 11790 | United States |
| Ophthalmic Consultants of Long Island | Valley Stream | New York | 11581 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2018 | Sep 17, 2018 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D011453 | Prostaglandins |
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D003008 | Cloprostenol |
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