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To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Tear | Other |
| |
| BRM421 Ophthalmic Solution, 0.03% | Active Comparator |
| |
| BRM421 Ophthalmic Solution, 0.06% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRM421 Ophthalmic Solution, 0.03% | Drug | A topical drop of 0.03% BRM421 ophthalmic solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total corneal fluorescein staining (tCFS) score | Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Alin Associate Director | Contact | +886-2-26598586 | alin.ning@brimbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Taipei Municipal TuCheng Hospital | New Taipei City | Taiwan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Artificial Tear | Drug | A topical drop of Artificial Tear. |
|
| BRM421 Ophthalmic Solution, 0.06% | Drug | A topical drop of 0.06% BRM421 ophthalmic solution. |
|
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |