Effect of topical administration of polycarbophil‐based formulation (DuraSite®) on an intact and surgically‐compromised corneal surface in rabbits

Abstract

Abstract Purpose The purpose of this investigation was to examine the effect of a polycarbophil‐based formulation in intact eyes and eyes compromised with a penetrating corneal incision, a LASIK flap or a full‐thickness epithelial defect. Methods New Zealand White rabbits were used. Polycarbophil (0.6 or 1.3%) was dosed in intact eyes TID for 1 year. The surgical models (penetrating surgical incision, LASIK flap, or 9 mm full‐thickness epithelial defect) were dosed with a 0.9% polycarbophil formulation. The eyes with the incision or flap were dosed QID for 14 days. Eyes with the epithelial defect were dosed 10 times in the first 24 h, then every 12 h for the next 2 days. The size of the defect was monitored with fluorescein. The eyes were examined histologically. Results In the 1 year study, no adverse ocular effects were observed at either dose of polycarbophil. In the incision model, administration of polycarbophil did not result in adverse findings; no anterior chamber reaction was observed. In the LASIK model, there were no adverse effects considered related to the polycarbophil. In the epithelial defect model, approximately half of the eyes demonstrated re‐epithelialization by 72 hours. The re‐epithelialization was not different from a saline control. Microscopically, there were no indications of adverse effects of the polycarbophil in any of the models assessed. Conclusion There are no adverse findings related to repeated topical administration of polycarbophil in uncompromised or surgically‐compromised rabbit eyes. These results support that polycarbophil (0.9%, DuraSite®) is safe to use in pharmaceutical preparations in both intact eyes and eyes with compromised ocular surfaces. Commercial interest