Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Aden... | NCT01349452

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

NCT01349452

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

May 6, 2011Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Conjunctivitis, Viral
Adenoviridae Infections

Interventions

Ganciclovir
Artificial tear

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

May 5, 2011

First Posted Date

May 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2011

Last Update Posted Date

May 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ganciclovir	Experimental		Drug: Ganciclovir
Artificial tear	Sham Comparator		Drug: Artificial tear

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganciclovir	Drug	Ganciclovir 0.15% Ophthalmic gel	Ganciclovir
Artificial tear

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement of symptoms of conjunctivitis (pain relief)		6 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simone T Yabiku, MD	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Sao Paulo		São Paulo	São Paulo	04023062	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22331114	Derived	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.

ID	Term
D003236	Conjunctivitis, Viral
D000257	Adenoviridae Infections
D054069	Multiple Acyl Coenzyme A Dehydrogenase Deficiency

ID	Term
D015828	Eye Infections, Viral
D015817	Eye Infections
D007239	Infections
D014777	Virus Diseases

ID	Term
D015774	Ganciclovir
D065346	Lubricant Eye Drops

ID	Term
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687