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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
Sponsor:
Information provided by (Responsible Party):
Southern California Institute for Research and Education

Study Description
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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.


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

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Veterans Affairs Long Beach Healthcare System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Southern California Institute for Research and Education
More Information
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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
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases
Azithromycin
Tobramycin
Povidone-Iodine
 Povidone
Anti-Bacterial Agents
Anti-Infective Agents
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local