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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349452
First Posted: May 6, 2011
Last Update Posted: May 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
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.

Condition Intervention
Conjunctivitis, Viral Adenoviridae Infections Drug: Ganciclovir Drug: Artificial tear

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • improvement of symptoms of conjunctivitis (pain relief) [ Time Frame: 6 days ]

Enrollment: 33
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ganciclovir Drug: Ganciclovir
Ganciclovir 0.15% Ophthalmic gel
Sham Comparator: Artificial tear Drug: Artificial tear
Artificial tear 5 times per day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349452


Locations
Brazil
Federal University of Sao Paulo
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Simone T Yabiku, MD Federal University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simone Tiemi Yabiku, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01349452     History of Changes
Other Study ID Numbers: GAN2011
First Submitted: April 29, 2011
First Posted: May 6, 2011
Last Update Posted: May 6, 2011
Last Verified: April 2011

Keywords provided by Federal University of São Paulo:
Conjunctivitis, Viral
Adenoviridae Infections
Ganciclovir
Adenovirus Keratoconjunctivitis
Treatment of viral conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Adenoviridae Infections
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
DNA Virus Infections
Virus Diseases
Eye Infections, Viral
Eye Infections
Ganciclovir
Ganciclovir triphosphate
Lubricant Eye Drops
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions