Clinical and virologic assesment of two therapeutic options: antiviral Ganciclovir 0.15% ophthalmic gel and physiologic saline solution 0.9% used in patients with acute adenoviral conjuntivitis.

INTERVENTION:

Trade Name: VIRGAN Gel oftálmico 1,5 mg/g Product Name: VIRGAN Gel oftálmico 1,5 mg/g Pharmaceutical Form: Eye gel INN or Proposed

INN:

2‐amino‐9‐{[(1,3‐dihydroxypropan‐2‐yl)oxy]methyl}‐6,9‐dihydro‐3H‐purin‐6‐one CAS Number: 82410‐32‐0 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1.5‐ Trade Name: Hidrathea Product Name: Hidrathea Pharmaceutical Form: Eye drops INN or Proposed

INN:

Sodium chloride CAS Number: 7647‐14‐5 Other descriptive name: Salt Concentration unit: mg/ml milligram(s)/millilitre Concentration type: not less then Concentration number: 9‐

CONDITION:

Acute adenoviral conjunctivitis ; MedDRA version: 18.0 Level: PT Classification code 10001257 Term: Adenoviral conjunctivitis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Eye Diseases [C11]

PRIMARY OUTCOME:

Main Objective: To evaluate the viral and clinical response reached by an antiviral drug (ganciclovir 0.15%) and an ocular hydrating agent (0.9%) in patients with acute adenoviral conjunctivitis. Primary end point(s): 1. Analysis of viral load from conjunctival samples of the patients.; 2. Analysis of the symptomatology described by the patient in agreement with listed symptoms specified in the protocol (foreing body sensation, photophobia, tearing, burning/itching).; 3. Analysis of clinical signs showed during ophthalmic examination (edema, injection, secretion, corneal staining, pseudomembranes). Secondary Objective: ‐To know the incidence of acute adenoviral conjunctivitis in the investigational site; ‐To identify the most frequent adenovitral strains foun in the investigational site; ‐To evaluate the most suggesting symptoms associated to adenoviral conjunctivitis; ‐To evaluate the safety of the two treatments used during the trial Timepoint(s) of evaluation of this end point: 1 D0 (basal value) and D2, D4 and D7; 2. D0 (basal value) and D4, D7, D21 and D90; 3. D0 (basal value) and D2, D4, and D7 (edema, injection, secretion, corneal staining, pseudomembranes).; D0 (basal value) and D21 and D90 (edema and pseudomembranes)

SECONDARY OUTCOME:

Secondary end point(s): ‐Analysis of visual acuity score by best corrected visual acuity parameter (BCVA); ‐Analysis and identification of local/systemic, simple/serious adverse reactions. Timepoint(s) of evaluation of this end point: ‐D0 (basal value) and D21, D90.; ‐During the whole study time.

INCLUSION CRITERIA:

1. Male or female aged ? 18 years old 2. Patients with uni or bilateral folicular conjunctivitis (7 days) and at least one of the following signs: ‐Tarsal micro‐haemorrhages ‐Preauricular lynphadenopathy ‐Previous or ongoing upper respiratory disease ‐Known history of recent contact with viral conjunctivitis ‐Iatrogenic exposure to viral infection (ophtlamologist, health‐care center) during last 7 days 3. Patients understanding complexity of the study and agree with signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8