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

Conjunctivitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349452
• Other study ID #: GAN2011
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: May 5, 2011
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviridae Infections
• Conjunctivitis
• Conjunctivitis, Viral

Intervention

Drug:
• Ganciclovir
Ganciclovir 0.15% Ophthalmic gel
• Artificial tear
Artificial tear 5 times per day

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of symptoms of conjunctivitis (pain relief)		6 days	No