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Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179412
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.

Condition Intervention Phase
Viral Conjunctivitis Drug: 2% povidone-iodine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • the recovery rate within one week of treatment [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • drug tolerability [ Time Frame: 1 week ]
    proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides


Enrollment: 172
Study Start Date: July 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2% povidone-iodine Drug: 2% povidone-iodine
apply 4 times a day for one week
Other Name: PVP-I
Drug: 2% povidone-iodine
apply 2% povidone-iodine 4 times per day for one week
Other Name: PVP-I

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179412


Locations
Thailand
Department of Ophthalmology, Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Adisak Trinavarat, MD Siriraj Hospital
  More Information

Responsible Party: Adisak Trinavara t/ Associate Professor, Department of Ophthalmology, Siriraj Hospital Mahidol University
ClinicalTrials.gov Identifier: NCT01179412     History of Changes
Other Study ID Numbers: EKC2004
First Submitted: July 18, 2010
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes