Conjunctivitis Clinical Trial
Official title:
"Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
Status | Not yet recruiting |
Enrollment | 22 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Adapt Produtos Oftalmológicos Ltda. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 10 days | No |
Secondary | 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) | 10 days | No |
Secondary | Degree of Bulbar conjunctival Injection | Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe | 10 days | No |
Secondary | 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) | 10 days | No |
Secondary | 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) | 10 days | No |
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