Sustained Corticosteroid Release From a Novel Therapeutic Contact Lens Drug Delivery System for the Treatment of Ocular Inflammation and Corneal Neovascularization
Abstract
Objective: The goal of this proposal is to develop medicated contact lens that can slowly release an anti-inflammatory medication to the eye. Background: A major unmet need in ophthalmology is a method of sustained ocular drug delivery to the front of the eye. Contact lens drug delivery, conceptualized in the 1960s, could achieve this goal by facilitating topical administration and reducing dosing frequency from hourly to weekly. However, controlling drug release from a contact lens and maintaining optical clarity have proven challenging. The underlying hypothesis of this application is that a drug-eluting therapeutic contact lens (TCL) can be designed to treat ocular inflammation. We developed an innovative TCL that demonstrated the capability of this lens to release a range of drugs that are used to treat bacterial infections and glaucoma. In animal testing, the TCL achieved sustained delivery of a therapeutic amount of drug for 1 month. Research Impact: A TCL could be used to release steroids to the eye. Topical steroids are an important part of ophthalmic therapy and are used to control ocular inflammation, prevent vision loss, speed recovery, and limit lost productivity following ocular surgery or trauma. Steroids are commonly used in a deployed setting for the treatment of iritis, a condition that can be severely limiting due to increased light sensitivity and ocular pain and often leaves Soldiers unable to do their normal everyday tasks. In the United States, iritis is treated with hourly dosing of steroid drops. This regimen is unrealistic in a deployed environment, and many patients are not able to maintain the uniform frequency required through the day and night. A TCL could be inserted by the patient or a health care profession and removed during follow-up. The continuous release of a medication would ensure that the patient s eye is receiving the medication. A TCL could be used to treat or prevent ocular inflammation following eye surgery, which may be required following combat-related trauma or to improve Soldier combat-readiness. Currently, bandage contact lenses and steroids drops are often used after corneal refractive procedures. A TCL would combine these treatment modalities. A TCL could prevent and treat vision loss associated with corneal vascularization, which can lead to corneal blindness, the second leading cause of blindness worldwide. Corneal blindness can be treated by corneal transplantation and approximately 40,000 are performed each year in the United States. Unfortunately, vascularization of the recipient cornea is the principal clinically detectable reason for transplant failure and can reduce graft survival rate from 85%-90% to less than 50%. This application proposes to complete proof-of-concept preclinical studies to support first-in-human testing and the clinical studies needed for regulatory approval and patient use. Military Benefit: A TCL could help to prevent the loss of vision after eye trauma. From 2000 to 2010, there were over 186,000 eye injuries to members of the U.S. Armed Forces. According to Department of Veterans Affairs data, eye trauma accounted for 15% of all battlefield injury and was the fourth most common injury during Operation Iraqi Freedom and Operation Enduring Freedom. A TCL could also help speed recovery after eye surgery. Each year approximately 40,000 corneal refractive procedures (e.g., LASIK) are performed on active military personnel and 50,000 cataract procedures are performed on Veterans. If this project is successful, Soldiers, Veterans, and civilians will have a completely new treatment option for treating blinding eye diseases.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 29, 2016
- Source ID
- W81XWH1510034
Entities
People
- Joseph B Ciolino
Organizations
- Schepens Eye Research Institute
- United States Army