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

Phase 3

• Conditions: Conjunctivitis; Adenovirus.
• Interventions: Drug: Ophthalmic gel (placebo); Drug: Ganciclovir

• Registration Number: NCT01600365
• Lead Sponsor: Adapt Produtos Oftalmológicos Ltda.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2011-03-22
• Status Verified: 2012-05
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-15
• Last Update Submitted: 2012-05-15
• Study First Posted: 2012-05-17
• Last Update Posted: 2012-05-17
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ophthalmic gel (placebo)	Ophthalmic gel (placebo)	ophthalmic gel (placebo)in the study eye
Ganciclovir	Ganciclovir	Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Primary Outcome Measures

Name	Time	Method
time to regression of the ocular symptomatology	10 days	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.

Secondary Outcome Measures

Name	Time	Method
Development of sub-epithelial infiltrates	10 days	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)
Degree of Bulbar conjunctival Injection	10 days	Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe
Involvement of the second eye	10 days	Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)
Patient Dairy - intensity of ocular pain	10 days	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)