The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
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)
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)
Medical Director
Clermont-Ferrand, France
efficacy of GV550
* The evolution of the inflammation * The virus load by quantitative PCR
Time frame: D0 to D4
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
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