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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01349452
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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	Phase
Conjunctivitis, Viral; Adenoviridae Infections	Drug: Ganciclovir; Drug: Artificial tear	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. improvement of symptoms of conjunctivitis (pain relief) [6 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01349452
• Other Study ID Numbers: GAN2011
• First Posted: May 6, 2011
• Last Update Posted: May 6, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: Conjunctivitis, Viral; Adenoviridae Infections; Ganciclovir; Adenovirus Keratoconjunctivitis; Treatment of viral conjunctivitis
• Additional relevant MeSH terms: Adenoviridae Infections; Conjunctivitis, Viral; Conjunctivitis; Ganciclovir; Ganciclovir triphosphate; Lubricant Eye Drops

Study Results

No Results Posted as of May 6, 2011