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Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01179412
Collaborator
(none)
172
Enrollment
1
Location
1
Arm
65
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 2% povidone-iodine
  • Drug: 2% povidone-iodine
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2% povidone-iodine

Drug: 2% povidone-iodine
apply 4 times a day for one week
Other Names:
  • PVP-I

    • Drug: 2% povidone-iodine
    apply 2% povidone-iodine 4 times per day for one week
    Other Names:
  • PVP-I

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the recovery rate within one week of treatment [1 week]

    Secondary Outcome Measures

    1. drug tolerability [1 week]

      proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Siriraj Hospital Mahidol University Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Adisak Trinavarat, MD, Siriraj Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01179412
    Other Study ID Numbers:
    • EKC2004
    First Posted:
    Aug 11, 2010
    Last Update Posted:
    Aug 11, 2010
    Last Verified:
    Aug 1, 2010
    Additional relevant MeSH terms:
    Conjunctivitis, Viral
    Conjunctivitis
    Keratoconjunctivitis
    Iodine
    Cadexomer iodine
    Povidone-Iodine
    Povidone

    Study Results

    No Results Posted as of Aug 11, 2010