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| ID | Type | Description | Link |
|---|---|---|---|
| CUNFI-0511-0814 |
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The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYL040012 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYL040012 | Drug | Administration of single and multiple doses of SYL040012 in ophthalmic drops solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Local tolerance after administration of one dose of SYL040012. | Part I: 3 days | |
| Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day. | Part II: 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics. | Part I: 1 hour, 1, 2, 3, days | |
| Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belen Sadaba, MD, PhD | Clínica Universitaria de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Part II: After each administration, at time 1 and 96 hours |