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Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01179412
First received: July 18, 2010
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • the recovery rate within one week of treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • drug tolerability [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Mahidol University
  More Information

No publications provided

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
Study First Received: July 18, 2010
Last Updated: August 10, 2010
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on June 17, 2013