Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Viral Conjunctivitis Clinical Trial

Official title:

Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179412
• Other study ID #: EKC2004
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2010
• Last updated: August 10, 2010
• Start date: July 2004
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral
• Keratoconjunctivitis
• Viral Conjunctivitis

Intervention

Drug:
• 2% povidone-iodine
apply 4 times a day for one week
• 2% povidone-iodine
apply 2% povidone-iodine 4 times per day for one week

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology, Siriraj Hospital Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the recovery rate within one week of treatment		1 week	No
Secondary	drug tolerability	proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides	1 week	Yes