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The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products(0.15%, 0.25% and vehicle)and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AL-43546 0.15% |
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| 2 | Experimental | AL-43546 0.25% |
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| 3 | Active Comparator | AL-43546 0%(Vehicle) |
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| 4 | Active Comparator | 0.1% sodium hyaluronate ophthalmic solutio |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxypropyl Guar Galactomannan | Drug | One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). | Up to 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular comfort | After installation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Pharmacology Clinical Research Hospital | Osaka | Osaka | 532-0003 | Japan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 0.1% sodium hyaluronate ophthalmic solution | Drug | One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods. |
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