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

NCT ID: NCT01560962

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

povidone iodine

Intervention Type DRUG

over the counter (OTC) 5% povidone iodine (PI)

No Intervention

Intervention Type OTHER

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.

Group Type OTHER

povidone iodine

Intervention Type DRUG

over the counter (OTC) 5% povidone iodine (PI)

warm soaked eyelid wash

Intervention Type OTHER

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.

Group Type OTHER

povidone iodine

Intervention Type DRUG

over the counter (OTC) 5% povidone iodine (PI)

Azithromycin

Intervention Type DRUG

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.

Group Type OTHER

povidone iodine

Intervention Type DRUG

over the counter (OTC) 5% povidone iodine (PI)

tobramycin-dexmethasone

Intervention Type DRUG

Interventions

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povidone iodine

over the counter (OTC) 5% povidone iodine (PI)

Intervention Type DRUG

No Intervention

Intervention Type OTHER

Azithromycin

Intervention Type DRUG

tobramycin-dexmethasone

Intervention Type DRUG

warm soaked eyelid wash

Intervention Type OTHER

Other Intervention Names

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Azasite

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Veterans Affairs Long Beach Healthcare System

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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blepharitis

Identifier Type: -

Identifier Source: org_study_id

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