Acute adenoviral conjunctivitis MedDRA version: 18.0 Level: PT Classification code 10001257 Term: Adenoviral conjunctivitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
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
Sponsors
Ana Boto de los Bueis
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Patients having viral conjunctivitis sympomathology longer tan 7 days. 2 Patients showing fluorescein-stained cornea: geographic or dendritic distribution. 3. Patients with corneal subepithelial infiltrates. 4. Patients with severe dry eye. 5. Intraocular inflammation (uveítis). 6. Patients under systemic corticoid treatment because of systemic pathology having no relation with any exclusión criteria. 7.Known history of atopy 8. Known history of allergy to medicinal study treatment active ingredients or any other ingredient. The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general and ethic conditions and exclusion criteria related to previous and concomitant medications/ non-product therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;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).;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactAlmudena del Hierro
Ana Boto de los Bueis
Outcome results
None listed