An interventional study of povidone iodine and No Intervention in Blepharitis, sponsored by Southern California Institute for Research and Education. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Southern California Institute for Research and Education · Not applicable, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Southern California Institute for Research and Education is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 · Other: 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.
Drug: povidone iodine · Other: 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.
Drug: povidone iodine · Drug: Azithromycin
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 · Drug: tobramycin-dexmethasone
over the counter (OTC) 5% povidone iodine (PI)
Also known as: Azasite
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.
Time frame: 01/12 to 01/13
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
Southern California Institute for Research and Education