Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Not Applicable

Terminated

• Conditions: Blepharitis
• Interventions: Drug: povidone iodine; Other: No Intervention; Other: warm soaked eyelid wash; Drug: tobramycin-dexmethasone; Drug: Azithromycin

• Registration Number: NCT01560962
• Lead Sponsor: Southern California Institute for Research and Education

Brief 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.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PI vs no intervention	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.
PI vs hygiene	warm soaked eyelid wash	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.
PI vs tobradex	tobramycin-dexmethasone	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.
PI vs no intervention	povidone iodine	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.
PI vs hygiene	povidone iodine	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.
PI vs azasite	povidone iodine	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.
PI vs azasite	Azithromycin	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.
PI vs tobradex	povidone iodine	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.

Primary Outcome Measures

Name	Time	Method
meibomian gland plugging	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.

Trial Locations

Locations (1)

Veterans Affairs Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States