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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01349452
First received: April 29, 2011
Last updated: May 5, 2011
Last verified: April 2011
History of Changes

April 29, 2011
May 5, 2011
August 2009
December 2009   (final data collection date for primary outcome measure)
improvement of symptoms of conjunctivitis (pain relief) [ Time Frame: 6 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01349452 on ClinicalTrials.gov Archive Site
Not Provided
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Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Conjunctivitis, Viral
  • Adenoviridae Infections
  • Drug: Ganciclovir
    Ganciclovir 0.15% Ophthalmic gel
  • Drug: Artificial tear
    Artificial tear 5 times per day
  • Experimental: Ganciclovir
    Intervention: Drug: Ganciclovir
  • Sham Comparator: Artificial tear
    Intervention: Drug: Artificial tear
Yabiku ST, Yabiku MM, Bottós KM, Araújo AL, de Freitas D, Belfort R Jr. [Ganciclovir 0.15% ophthalmic gel in the treatment of adenovirus keratoconjuntivitis]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01349452
GAN2011
No
Simone Tiemi Yabiku, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Simone T Yabiku, MD Federal University of Sao Paulo
Federal University of São Paulo
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP