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

This study has been terminated.

(research staffs unable to continue.)

Sponsor:

Information provided by (Responsible Party):

Southern California Institute for Research and Education

ClinicalTrials.gov Identifier:

NCT01560962

First received: March 20, 2012

Last updated: May 28, 2013

Last verified: May 2013

History of Changes

Purpose

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	Intervention
Blepharitis	Drug: povidone iodine Drug: Povidone-Iodine Drug: Azithromycin Drug: tobramycin-dexmethasone


Study Type:	Interventional
Official Title:	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Resource links provided by NLM:

MedlinePlus related topics: Over-the-Counter Medicines

Drug Information available for: Iodine Povidone Povidone-iodine Tobramycin

U.S. FDA Resources

Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:

meibomian gland plugging [ Time Frame: 01/12 to 01/13 ] [ Designated as safety issue: No ]
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.


Study Start Date:	January 2012
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PI vs no intervention	Drug: povidone iodine
PI vs hygiene	Drug: Povidone-Iodine
PI vs azasite	Drug: Azithromycin
PI vs tobradex	Drug: tobramycin-dexmethasone

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560962

Locations


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


Responsible Party:	Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:	NCT01560962 History of Changes
Other Study ID Numbers:	blepharitis
Study First Received:	March 20, 2012
Last Updated:	May 28, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Blepharitis Eyelid Diseases Eye Diseases Iodine Cadexomer iodine Povidone-Iodine Tobramycin Povidone Anti-Infective Agents, Local	Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Anti-Bacterial Agents Plasma Substitutes Blood Substitutes

ClinicalTrials.gov processed this record on September 28, 2016

To Top