Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
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ClinicalTrials.gov Identifier: NCT01560962 |
Recruitment Status :
Terminated
(research staffs unable to continue.)
First Posted : March 22, 2012
Last Update Posted : March 17, 2021
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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 Other: No Intervention Drug: Azithromycin Drug: tobramycin-dexmethasone Other: warm soaked eyelid wash | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
PI vs no intervention
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.
|
Drug: povidone iodine
over the counter (OTC) 5% povidone iodine (PI) Other: No Intervention |
PI vs hygiene
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.
|
Drug: povidone iodine
over the counter (OTC) 5% povidone iodine (PI) Other: warm soaked eyelid wash |
PI vs azasite
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.
|
Drug: povidone iodine
over the counter (OTC) 5% povidone iodine (PI) Drug: Azithromycin Other Name: Azasite |
PI vs tobradex
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.
|
Drug: povidone iodine
over the counter (OTC) 5% povidone iodine (PI) 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Responsible Party: | Southern California Institute for Research and Education |
ClinicalTrials.gov Identifier: | NCT01560962 |
Other Study ID Numbers: |
blepharitis |
First Posted: | March 22, 2012 Key Record Dates |
Last Update Posted: | March 17, 2021 |
Last Verified: | March 2021 |
Blepharitis Eyelid Diseases Eye Diseases Azithromycin Tobramycin Povidone-Iodine |
Povidone Anti-Bacterial Agents Anti-Infective Agents Plasma Substitutes Blood Substitutes Anti-Infective Agents, Local |