Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
|ClinicalTrials.gov Identifier: NCT01560962|
Recruitment Status : Terminated (research staffs unable to continue.)
First Posted : March 22, 2012
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Blepharitis||Drug: povidone iodine Drug: Povidone-Iodine Drug: Azithromycin Drug: tobramycin-dexmethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|PI vs no intervention||Drug: povidone iodine|
|PI vs hygiene||Drug: Povidone-Iodine|
|PI vs azasite||Drug: Azithromycin|
|PI vs tobradex||Drug: tobramycin-dexmethasone|
- meibomian gland plugging [ Time Frame: 01/12 to 01/13 ]
Variables of interest will include:
A. Subjective Measures including patient-rated symptom scores for 1. Itching (grade 0-3) 2. foreign body sensation (grade 0-3) 3. ocular dryness (grade 0-3) 4. ocular burning (grade 0-3) and 5. swollen eyelids (grade 0-3) B. Objective Measures: Evaluation of 1. lid margin redness (grade 0-3) 2. meibomian gland plugging (grade 0-3) and 3. Presence of collarets and scurfs (Grade 0-3) 4. Cultures of eyelid margin at the start and at the conclusion of treatment at 10 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560962
|United States, California|
|Veterans Affairs Long Beach Healthcare System|
|Long Beach, California, United States, 90822|