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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Federal University of São Paulo

Additional 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
Study First Received: April 29, 2011
Last Updated: May 5, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Infection
Conjunctivitis
Adenoviridae Infections
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
DNA Virus Infections
Virus Diseases
Eye Infections, Viral
Eye Infections
Ophthalmic Solutions
Ganciclovir
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014