Treatment of Epidemic Keratoconjunctivitis With 2% Povido... | NCT01179412

Studies
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

NCT01179412

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Aug 11, 2010Estimated

Enrollment

172Actual

Phase

Phase 4

Conditions

Viral Conjunctivitis

Interventions

2% povidone-iodine
2% povidone-iodine

Countries

Thailand

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

Aug 2010

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

Jul 2004

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 18, 2010

First Submission Date that Met QC Criteria

Aug 10, 2010

First Posted Date

Aug 11, 2010Estimated

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

Aug 10, 2010

Last Update Posted Date

Aug 11, 2010Estimated

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

The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.

Detailed Description

The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2% povidone-iodine	Experimental		Drug: 2% povidone-iodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2% povidone-iodine	Drug	apply 4 times a day for one week	2% povidone-iodine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the recovery rate within one week of treatment		1 week

Secondary Outcomes

Measure	Description	Time Frame
drug tolerability	proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who were diagnosed with EKC at the outpatient ophthalmic unit

Exclusion Criteria:

children younger than six years
women being pregnant or during lactation
history of allergy to povidone-iodine
prior ocular surgery
contact lens usage and chronic eye diseases with current eye medications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adisak Trinavarat, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Siriraj Hospital Mahidol University		Bangkoknoi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D003236	Conjunctivitis, Viral

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011206	Povidone-Iodine

Ancestor Terms

ID	Term
D007466	Iodophors
D017613	Iodine Compounds
D007287	Inorganic Chemicals
D011145	Polyvinyls

Browse Leaves

Not provided

Browse Branches

Not provided