NCT01179412

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

5.4 years

First QC Date

July 18, 2010

Last Update Submit

August 10, 2010

Conditions

Viral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • the recovery rate within one week of treatment

    1 week

Secondary Outcomes (1)

  • drug tolerability

    1 week

Study Arms (1)

2% povidone-iodine

EXPERIMENTAL
Drug: 2% povidone-iodine

Interventions

2% povidone-iodineDRUG

apply 4 times a day for one week

Also known as: PVP-I
2% povidone-iodine

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were diagnosed with EKC at the outpatient ophthalmic unit

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Conjunctivitis, Viral

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Adisak Trinavarat, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2010

First Posted

August 11, 2010

Study Start

July 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations

TH(1)