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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | One drop of 0.001% AG-80308, two times daily to both eyes for 3 months |
|
| Group 2 | Experimental | One drop of 0.03% AG-80308, two times daily to both eyes for 3 months |
|
| Group 3 | Experimental | One drop of 0.1% AG-80308, two times daily to both eyes for 3 months |
|
| Group 4 | Experimental | One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-80308 | Drug | AG-80308 Eye Drop Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adverse events (AEs) and serious AEs (SAEs) | Screening to 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in ocular surface staining | Screening to 3 months | |
| Mean change from baseline in dry eye symptoms | Screening to 3 months | |
| Mean change from baseline in Schirmer's test |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States | ||
| Andover Eye Associates |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Screening to 3 months |
| Raynham |
| Massachusetts |
| 02767 |
| United States |
| Alpine Research Organization, Inc. | Clinton | Utah | 84015 | United States |