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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014