Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Information source: Southern California Institute for Research and Education
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharitis
Intervention: povidone iodine (Drug); Povidone-Iodine (Drug); Azithromycin (Drug); tobramycin-dexmethasone (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Southern California Institute for Research and Education
Summary
Objective: To determine the preliminary outcome of external over the counter (OTC) povidone
iodine (PI) application in the management of chronic and acute blepharitis vs. currently
clinically accepted medical regimen, i. e. eyelid hygiene, antibiotic drops, or
antibiotic/steroid ointments.
Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled
and randomized into four groups.
In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI
twice daily for 10 days and the other eye with no intervention.
In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI
and the other eye will receive warm soaked eyelid wash.
In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI
and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10
days.
In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI
and the other eye will receive tobradex ointment applied to the lid margin.
Subjective variables assessed included itchiness, foreign body sensation and eyelid edema
(grade 0-4). Objective variables assessed included lid margin redness, meibomian gland
plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the
initiation and at the cessation of treatment were obtained.
Clinical Details
Official title: Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Study design: N/A
Primary outcome: meibomian gland plugging
Detailed description:
Final statiscial analysis for subjective and objective numerical values following treatment
for each group of subjects (group 2,3,4) should show equal or almost equal efficacy in
treatment of blepharitis.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All potential subjects with symptomatic blepharitis examined to have blepharitis with
healthy mental status, able to give consent, with/without co-existing medical
consitions will be considered.
Exclusion Criteria:
- All subjects with history and/or probable history of allergic reaction to
povidine-iodine, azithromycin, & tobramycin/dexamethasone and all subjects who have
mental disability and are unable to give direct consent will be excluded
Locations and Contacts
Veterans Affairs Long Beach Healthcare System, Long Beach, California 90822, United States
Additional Information
Starting date: January 2012
Last updated: May 28, 2013
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