- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349452
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
May 5, 2011 updated by: Federal University of São Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 04023062
- Federal University of São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ganciclovir
|
Ganciclovir 0.15% Ophthalmic gel
|
Sham Comparator: Artificial tear
|
Artificial tear 5 times per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement of symptoms of conjunctivitis (pain relief)
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simone T Yabiku, MD, Federal University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
April 29, 2011
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Estimate)
May 6, 2011
Last Update Submitted That Met QC Criteria
May 5, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- DNA Virus Infections
- Conjunctival Diseases
- Eye Infections
- Eye Infections, Viral
- Conjunctivitis
- Adenoviridae Infections
- Conjunctivitis, Viral
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Lubricant Eye Drops
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- GAN2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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