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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002455-16 | EudraCT Number |
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The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GV550 | Experimental | (Ganciclovir 1.5 mg/g ophtalmic gel) |
|
| Placebo | Placebo Comparator | Placebo ophtalmic gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GV550 | Drug | Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30) |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of GV550 |
| D0 to D4 |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of GV550 |
| |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Director | Clermont-Ferrand | 63000 | France |
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| placebo | Drug | 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30) |
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| Ocular safety |
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| Systemic safety | - To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit |