TOPICAL FIBRONECTIN OPHTHALMIC SOLUTION IN THE TREATMENT OF PERSISTENT DEFECTS OF THE CORNEAL EPITHELIUM

PURPOSE: We sought to evaluate the efficacy of topical fibronectin oph thalmic solution, containing 3.5 mg/ml of human fibronectin, in the tr eatment of persistent epithelial defects of the cornea. METHODS: In a double masked, randomized clinical trial, patients with a persistent, corneal epithelial defect of at least 14 days in duration, and at leas t 2 mm in width along the larger axis, were sought from the practices of 38 clinical investigators. After a 14-day washout period, 65 patien ts were randomly assigned to one of three treatment groups. One group (n = 20) received fibronectin drops; the second (n = 23) received drop s of the vehicle from the fibronectin solution; and the third (n = 22) received a placebo. RESULTS: After 21 days of treatment, there was no difference in percentage reduction of the corneal epithelial defect s ize; the average percentage of reduction of defect area ranged from 46 .5% to 54,3%. Fibronectin treatment showed a beneficial effect for pat ients with larger baseline defects (10 mm(2) or greater in area); howe ver, no such effect was observed among patients with smaller defects. Defect duration before treatment had a significant effect on outcome ( P = .007); defects of longer duration were less likely to decrease in size over the course of the study. CONCLUSIONS: All three treatment gr oups showed similar reductions in defect size; therefore, this study p rovides no support for the efficacy of fibronectin treatment of persis tent, corneal epithelial defects. Defect duration showed a negative as sociation with reduction in defect size. Because strict control of top ical applications during the washout and treatment periods resulted in beneficial responses, physicians should carefully consider the topica l medications used by patients who have persistent, corneal epithelial defects.