Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis

Not Applicable

Completed

• Conditions: Conjunctivitis, Viral; Adenoviridae Infections
• Interventions: Drug: Artificial tear; Drug: Ganciclovir

• Registration Number: NCT01349452
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. The majority of adenoviral conjunctivitis will resolve without damaging vision, however, the investigators have no way to determine which cases will progress to ocular complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2011-04
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-05
• Last Update Submitted: 2011-05-05
• Study First Posted: 2011-05-06
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• onset of symptoms for five days or less
• eighteen years old or more
• not pregnant or breastfeeding
• be able to understand and sign the consent term

Exclusion Criteria

• use of antibiotic or corticoid 30 days before
• monocular vision
• keratopathy or other ocular diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial tear	Artificial tear	-
Ganciclovir	Ganciclovir	-

Primary Outcome Measures

Name	Time	Method
improvement of symptoms of conjunctivitis (pain relief)	6 days

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 São Paulo, Brazil