Nanosphere-Antibiotic Corneal Contact Lens Delivery System

DESCRIPTION (provided by applicant): Nanosphere technology will be utilized for controlled ophthalmic antibiotic delivery via a hydrogel polymer contact lens device. The device will be useful for a number of conditions including traumatic injury, surface disorders, and post-surgical healing. The advantage of this medicated bandage system over traditional therapy is that a consistent dose of antibiotic (ciprofloxacin) will be delivered over a 7-14 day period while protecting the cornea with a hydrogel banda ge lens. The sustained delivery of ciprofloxacin precludes the use of topical antibiotic drops, resulting in improved patient compliance, convenience, and subsequent efficacy. The bandage effect of the device assists in pain relief and wound healing at the surface of the eye, as is commonly done using current, non-medicated hydrogel bandage contact lenses. The nanosphere technology utilized in this project allows for customized encapsulation to control drug release. These nanospheres are unique in that they are based on a carbohydrate core, and have a hydrophilic shell rendering it compatible with a hydrophilic system such as our hydrogel contact lens material. They are biodegradable, non-toxic, and stable in solution. Both the shell and the core can be func tionalized independently, allowing for modifications and enhancements to further control drug release. The specific aims of this project during year 1 include synthesis of the nanospheres and encapsulation of the antibiotic; polymerization of the nanospher es into the hydrogel material suitable for ocular use; and testing the release characteristics of the antibiotic from the hydrogel lenses. During year 2 of this project, the casting and manufacturing specifics for the lenses will be determined, and the pre -clinical safety and efficacy of the lenses will be tested, according to FDA guidelines. PUBLIC HEALTH RELEVANCE: The product in development will improve patient care by providing a more efficient, convenient, and consistent means of antibiotic drug delive ry to the surface of the eye, while serving as a bandage to decrease intense ocular pain and to aid in ocular surface healing. This product will eliminate the necessity of giving frequent doses of antibiotic drops for a wide range of conditions compromisin g the surface of the eye. Such common conditions include active infections of the cornea and conjunctiva, as well as for prevention of pain or potential infection associated with severe dry eye, trauma, or ocular surgery such as cataract, glaucoma or laser refractive surgery procedures.