Study of the comparative efficacy of two different treatments used in acute conjunctivitis by adenovirus: Ganciclovir 0.15% and saline solution 0.9%.
- Conditions
- Acute adenoviral conjunctivitisMedDRA version: 18.0Level: PTClassification code 10001257Term: Adenoviral conjunctivitisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-002319-41-ES
- Lead Sponsor
- Ana Boto de los Bueis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method