Back to resultsTreatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Primary Purpose
Viral Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
2% povidone-iodine
2% povidone-iodine
Sponsored by
About this trial
This is an interventional treatment trial for Viral Conjunctivitis
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.
Sites / Locations
- Department of Ophthalmology, Siriraj Hospital Mahidol University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2% povidone-iodine
Arm Description
Outcomes
Primary Outcome Measures
the recovery rate within one week of treatment
Secondary Outcome Measures
drug tolerability
proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179412
Brief Title
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Official Title
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2% povidone-iodine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
2% povidone-iodine
Other Intervention Name(s)
PVP-I
Intervention Description
apply 4 times a day for one week
Intervention Type
Drug
Intervention Name(s)
2% povidone-iodine
Other Intervention Name(s)
PVP-I
Intervention Description
apply 2% povidone-iodine 4 times per day for one week
Primary Outcome Measure Information:
Title
the recovery rate within one week of treatment
Time Frame
1 week
Secondary Outcome Measure Information:
Title
drug tolerability
Description
proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adisak Trinavarat, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Siriraj Hospital Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
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