search
Back to results

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

Primary Purpose

Blepharitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
povidone iodine
No Intervention
Azithromycin
tobramycin-dexmethasone
warm soaked eyelid wash
Sponsored by
Southern California Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Veterans Affairs Long Beach Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

PI vs no intervention

PI vs hygiene

PI vs azasite

PI vs tobradex

Arm Description

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.

Outcomes

Primary Outcome Measures

meibomian gland plugging
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2012
Last Updated
March 15, 2021
Sponsor
Southern California Institute for Research and Education
search

1. Study Identification

Unique Protocol Identification Number
NCT01560962
Brief Title
Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Official Title
Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
research staffs unable to continue.
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California Institute for Research and Education

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PI vs no intervention
Arm Type
Other
Arm Description
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.
Arm Title
PI vs hygiene
Arm Type
Other
Arm Description
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.
Arm Title
PI vs azasite
Arm Type
Other
Arm Description
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.
Arm Title
PI vs tobradex
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
povidone iodine
Intervention Description
over the counter (OTC) 5% povidone iodine (PI)
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Azasite
Intervention Type
Drug
Intervention Name(s)
tobramycin-dexmethasone
Intervention Type
Other
Intervention Name(s)
warm soaked eyelid wash
Primary Outcome Measure Information:
Title
meibomian gland plugging
Description
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.
Time Frame
01/12 to 01/13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Veterans Affairs Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs