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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023113-56 | EudraCT Number |
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The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYL1001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYL1001 | Drug | SYL1001 eye drops. topical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2. | Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale in cases where asubjects refers them | Period I: 3 days, Period II: 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2) | Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects | Period I: 3 days; Period II: 11 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belen Sadaba, MD, PhD | Clinica Universidad de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27893109 | Derived | Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303. |
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| ID | Term |
|---|---|
| D058447 | Eye Pain |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D007766 | Lacrimal Apparatus Diseases |