Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
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 More Information
No publications provided
| 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: | December 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blepharitis Eyelid Diseases Eye Diseases Povidone Tobramycin Azithromycin Cadexomer iodine Iodine Povidone-Iodine Plasma Substitutes Blood Substitutes |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Anti-Infective Agents, Local Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013