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| Name | Class |
|---|---|
| Hospital Universitario Principe de Asturias | OTHER |
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Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaCl 5% | Experimental | Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose | Device | Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Visual acuity | Baseline, Day 7 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Corneal Thickness | Micrometers | Baseline, Day 7 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events (Objective Tolerance) | Slit Lamp Examination | Baseline, Day 7 and Day 28 |
| Score in Subjective Tolerance Test | Day 7 and Day 28 |
Inclusion Criteria:
Exclusion Criteria:.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiedra Farmaceutica | Contact | +34 91 643 41 40 | info@tiedra.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Príncipe de Asturias | Alcalá de Henares | Spain |
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| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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