Clinical Trial: A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers
Brief 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.
Detailed Summary:
Hypothesis to be tested:
Infectious corneal ulceration causes corneal scarring, opacification, and blindness in hundreds of thousands of children annually. In developing countries, it is the number one cause of avoidable blindness in children. While in some cases, the cornea was healthy prior to ulceration, in others; xerophthalmia, trachoma, rubeola, trauma, or some other cause previously compromised the cornea. Even when the ulceration is associated with one of the above etiologies, it is usually the bacterial corneal ulcer that directly leads to blindness in the short-term. In many countries, few of these infections are properly treated with appropriate antimicrobial agents due to a number of factors, including cost, availability, and effectiveness. If a topical antimicrobial agent were readily available in developing countries which is also inexpensive and effective, many of these ulcers could be cured before scarring and blindness result.
The best candidate for such a medication is povidone-iodine ophthalmic solution. It has already been proven the best agent to sterilize the ocular surface before and after eye surgery and to prevent conjunctivitis in newborn babies. It was also shown an effective treatment against bacterial conjunctivitis in children. Povidone-iodine ophthalmic solution can be prepared in a local hospital or clinic by mixing the powder with an ophthalmic saline solution bringing the cost of a 10-ml bottle to less than US $0.10. By contrast, in the Philippines, a 10 ml. bottle of Neosporin ophthalmic solution cost about $4.00 and it may take a few bottles to cure a bacterial corneal ulcer. For far less than a U.S. dollar, a corneal ulcer could be fully cured. Povidone-iodine has the widest antimicrobial spectrum of any known topical medication. It has been shown to be effective against all bacteria, f
Sponsor: Los Angeles Biomedical Research Institute
Current Primary Outcome:
- Days to cure, with corneal epithelial defect closed, and no inflammatory signs other than minimal injection.
- Safety of study medication use compared to control medications. No untoward reactions or loss of visual acuity (VA) compared with pre-treatment VA findings.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Los Angeles Biomedical Research Institute
Dates:
Date Received: October 11, 2006
Date Started: November 2002
Date Completion:
Last Updated: August 22, 2016
Last Verified: October 2006
