Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

Adapt Produtos Oftalmológicos Ltda.22 enrolled

Overview

The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.

To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Conjunctivitis Adenovirus.

Interventions

Ophthalmic gel (placebo)DRUG

Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days

GanciclovirDRUG

Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis. * Patients of both gender aged over 18 years. * Patients who are not pregnant or nursing. * Patients able (legally and mentally) to understand and sign informed consent had been signed. Exclusion Criteria: * Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension. * Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk. * Patient with a single eye or vision in one eye.

Outcomes

Primary Outcomes

time to regression of the ocular symptomatology

Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.

Time frame: 10 days

Secondary Outcomes

Development of sub-epithelial infiltrates

Development of sub-epithelial infiltrates,incidence for the study duration and severity at each follow-up visit (based on scale of absent, mild, moderate and severe)

Time frame: 10 days

Degree of Bulbar conjunctival Injection

Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe

Time frame: 10 days

Involvement of the second eye

Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)

Time frame: 10 days

Patient Dairy - intensity of ocular pain

intensity of ocular pain selected by the patient on the "Patient Dairy" based on the visual analogue scale (VAS)on each follow-up visit (absent, mild, moderate, severe)

Time frame: 10 days

Central Contacts

Rubens Belfort, PhD, MD

CONTACT

5511 55726443 rogeriomazon@adaptltda.com.br

Cristina Muccioli, MD

CONTACT

5511 55726443

Data from ClinicalTrials.gov

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