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

"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.

Study Overview

• Status: Unknown
• Conditions: Conjunctivitis; Adenovirus.
• Intervention / Treatment: Drug: Ganciclovir; Drug: Ophthalmic gel (placebo)

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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rubens Belfort, PhD, MD; Phone Number: 5511 55726443; Email: rogeriomazon@adaptltda.com.br
• Study Contact Backup: Name: Cristina Muccioli, MD; Phone Number: 5511 55726443

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Investigators: Principal Investigator: Rubens Belfort, PhD, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 17, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Conjunctivitis; adenovirus.
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; DNA Virus Infections; Conjunctival Diseases; Conjunctivitis; Adenoviridae Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: ADA-GAN-02/10