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

NCT01349452 | Completed

• 1 other identifier: GAN2011
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis, Viral; Adenoviridae Infections

Keywords

Conjunctivitis, Viral; Adenoviridae Infections; Ganciclovir; Adenovirus Keratoconjunctivitis; Treatment of viral conjunctivitis

Outcome Measures

Primary Outcomes (1)

• improvement of symptoms of conjunctivitis (pain relief)

  6 days

Study Arms (2)

Ganciclovir

EXPERIMENTAL

Drug: Ganciclovir

Artificial tear

SHAM COMPARATOR

Drug: Artificial tear

Interventions

Ganciclovir DRUG

Ganciclovir 0.15% Ophthalmic gel

Ganciclovir

Artificial tear DRUG

Artificial tear 5 times per day

Artificial tear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• use of antibiotic or corticoid 30 days before
• monocular vision
• keratopathy or other ocular diseases

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023062, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22331114 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Viral; Adenoviridae Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Ganciclovir; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Virus Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases; DNA Virus Infections; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Simone T Yabiku, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 6, 2011
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 6, 2011

Record last verified: 2011-04

Locations

BR (1)