A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers (NCT00386958) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers
United States172 participantsStarted 2002-11
Plain-language summary
Bacterial corneal ulcers are a leading cause of pediatric blindness in underdeveloped countries due to a lack of antibiotic availability and affordability, among other reasons. Povidone-iodine, an inexpensive and readily available broad-spectrum antimicrobial agent, may be an effective and affordable treatment for corneal ulcers, allowing preservation of sight for those afflicted with this disease.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of untreated bacterial corneal ulcer that began within 14 days of presentation to the study center.
* Corneal ulcer size is 2 mm-8 mm. in diameter, and does not extend to the limbus.
Exclusion Criteria:
* Topical or systemic antimicrobial or immunosuppressant therapy within 14 days of presentation to the study center.
* Corneal ulcer smear and culture fail to show the presence of bacteria.
* Allergic history to povidone-iodine, iodine or any components of Neosporin.
* Dacrocystitis, neurotropic or exposure keratitis, keratitis sicca, positive HIV status, and legal blindness in the unaffected eye.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days to cure, with corneal epithelial defect closed, and no inflammatory signs other than minimal injection.
2
Safety of study medication use compared to control medications. No untoward reactions or loss of visual acuity (VA) compared with pre-treatment VA findings.
Trial details
NCT IDNCT00386958
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center