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

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

Detailed Description
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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.

Official Title
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Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus.

Conditions
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Conjunctivitis, Adenovirus.

Intervention / Treatment
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* Drug: Ophthalmic gel (placebo)
* Drug: Ganciclovir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ganciclovir<br>Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days | Drug: Ganciclovir<br>* Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days<br>* Other names: ganciclovir gel;|
| Placebo Comparator: Ophthalmic gel (placebo)<br>ophthalmic gel (placebo)in the study eye | Drug: Ophthalmic gel (placebo)<br>* Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days<br>* Other names: artificial tears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conjunctivitis, adenovirus.