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NCT01560962 · ClinicalTrials.gov registry record · NA
Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
A NA study, sponsored by Southern California Institute for Research and Education.
- Terminated
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01560962: Clinical Trial NA study, sponsored by Southern California Institute for Research and Education.
NCT01560962 is a NA study that was terminated before completion, run by Southern California Institute for Research and Education. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560962, a NA study, was terminated before completion, sponsored by Southern California Institute for Research and Education.
- TERMINATED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
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 a
Interventions
- OTHER No Intervention
- DRUG Azithromycin
- DRUG povidone iodine
- DRUG tobramycin-dexmethasone
- OTHER warm soaked eyelid wash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-12 |
| Phase | NA |
Why NCT01560962 stopped before completion
NCT01560962 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which No Intervention is the first listed.
NCT01560962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560962 about?
NCT01560962 is a clinical study titled "Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis". 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. Methodolo...
What is the current status of trial NCT01560962?
This trial is currently terminated. It is a NA study. The enrollment target is 100 participants. The study started on 2012-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01560962?
The interventions under investigation include: No Intervention (OTHER), Azithromycin (DRUG), povidone iodine (DRUG), tobramycin-dexmethasone (DRUG), warm soaked eyelid wash (OTHER).
Who is sponsoring clinical trial NCT01560962?
This trial is sponsored by Southern California Institute for Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01560962's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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