Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)

Conditions
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Acute Adenoviral Keratoconjunctivitis

Intervention / Treatment
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* Drug: GV550
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Male or female aged from 18 to 80 years old Acute adenoviral keratoconjunctivitis Exclusion Criteria: Active ocular allergy Ocular herpès disease History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GV550<br>(Ganciclovir 1.5 mg/g ophtalmic gel) | Drug: GV550<br>* 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)<br>|
| Placebo Comparator: Placebo<br>Placebo ophtalmic gel | Drug: placebo<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of GV550 | The evolution of the inflammation The virus load by quantitative PCR | D0 to D4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of GV550 | The assessment of the patient's symptomatology evaluation The score of each subjective signs The score of each objective signs The occurrence of focal corneal sub epithelial infiltrates (nummular stromal infiltration) The occurrence of pseudo membranes The virus load between D0-D10 |  | 
| Ocular safety | To compare the ocular tolerance of GV550 eye drops versus placebo eye drops with respect of the assessment of the global local tolerance assessment by the investigator and by the patient To compare the ocular safety of GV550 eye drops versus placebo eye drops with respect of the assessment of the best corrected far visual acuity and ocular Adverse Event (AE) reporting at each visit |  | 
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GV550, Acute adenoviral keratoconjunctivitis