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

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ClinicalTrials.gov Identifier: NCT01349452
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Information provided by:
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.

Condition or disease Intervention/treatment
Conjunctivitis, Viral Adenoviridae Infections Drug: Ganciclovir Drug: Artificial tear

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Study Start Date : August 2009
Primary Completion Date : December 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ganciclovir Drug: Ganciclovir
Ganciclovir 0.15% Ophthalmic gel
Sham Comparator: Artificial tear Drug: Artificial tear
Artificial tear 5 times per day

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

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

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

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

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

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 Posted: May 6, 2011    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Adenoviridae Infections
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
DNA Virus Infections
Virus Diseases
Eye Infections, Viral
Eye Infections
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