Topical autologous fibronectin in patients with recurrent corneal epithelial defects

We designed a clinical trial to evaluate the effect of topical fibronectin (an adhesive protein) for prevention of recurrent corneal epithelial defects. Fifteen eyes (11 patients) with 2 documented epithelial defects within 12 weeks were included. Purity and biological activity of the prepared solutions of autologous plasma fibronectin were confirmed by sodium dodecyl-sulfate polyacrylamide gel electrophoresis and gelatin binding affinity, respectively. According to randomization, fibronectin or saline was given 5 times per day for 11 weeks to 1 eye of 11 patients. Eyes of 4 patients with bilateral disease were paired, 1 eye receiving fibronectin and the other saline. We examined the patients weekly. The following recurrence parameters were retained for analysis: number of weeks with an epithelial defect, area under recurrence curves, and number of weeks with discomfort. The randomized and paired data analyses suggest that topical autologous plasma fibronectin does not prevent recurrent corneal epithelial defects. We describe a patient who received two treatment courses bilaterally, each eye crossing over to the alternate medication after a first treatment course. The response to treatment of each eye appeared unassociated to the medication.