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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00866-51 | Registry Identifier | IDRCB |
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The purpose of this open, non-comparative, multicenter trial is to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SygeLIX-Coll-T | Experimental | Extract of umbilical cord lining constituted of Wharton's jelly put in suspension in microvials. Instillation by the patient in the sick eye of 1 drop 5 times a days (morning, noon, afternoon, evening and bedtime) for 40 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SygeLIX-Coll-T | Biological | Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect | Inflammatory signs evaluated using a composite score on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye | Through study completion - average of 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Re-epithelialization of the cornea | Epithelialization assessed by the Oxford score after fluorescein instillation in the eye (0: no corneal staining to 5: severe corneal staining) | 7 days, 15 days, 40 days |
| Improvement of dry eyes signs and symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Michallon, CHU de Grenoble | La Tronche | 38700 | France | |||
| Hôpital Gui de Chauliac, CHU de Montpellier |
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| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire
| 7 days, 15 days, 40 days |
| Improvement of visual acuity | Visual acuity evaluated on Monoyer chart | 7 days, 15 days, 40 days |
| Montpellier |
| 34295 |
| France |
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | 75012 | France |
| Hôpital Fondation Adolphe de Rothschild | Paris | 75019 | France |
| Hôpital Charles-Nicolle, CHU de Rouen | Rouen | 76000 | France |
| Hôpital Nord, CHU de Saint-Etienne | Saint-Priest-en-Jarez | 42270 | France |
| D005128 |
| Eye Diseases |