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

Primary Purpose

Conjunctivitis, Viral, Adenoviridae Infections

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ganciclovir
Artificial tear
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis, Viral focused on measuring Conjunctivitis, Viral, Adenoviridae Infections, Ganciclovir, Adenovirus Keratoconjunctivitis, Treatment of viral conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ganciclovir

Artificial tear

Arm Description

Outcomes

Primary Outcome Measures

improvement of symptoms of conjunctivitis (pain relief)

Secondary Outcome Measures

Full Information

First Posted
April 29, 2011
Last Updated
May 5, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01349452
Brief Title
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Official Title
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Viral, Adenoviridae Infections
Keywords
Conjunctivitis, Viral, Adenoviridae Infections, Ganciclovir, Adenovirus Keratoconjunctivitis, Treatment of viral conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganciclovir
Arm Type
Experimental
Arm Title
Artificial tear
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Intervention Description
Ganciclovir 0.15% Ophthalmic gel
Intervention Type
Drug
Intervention Name(s)
Artificial tear
Intervention Description
Artificial tear 5 times per day
Primary Outcome Measure Information:
Title
improvement of symptoms of conjunctivitis (pain relief)
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone T Yabiku, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22331114
Citation
Yabiku ST, Yabiku MM, Bottos KM, Araujo AL, Freitas Dd, Belfort R Jr. [Ganciclovir 0.15% ophthalmic gel in the treatment of adenovirus keratoconjunctivitis]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. doi: 10.1590/s0004-27492011000600007. Portuguese.
Results Reference
derived

Learn more about this trial

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

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