Ocular tolerance of sertaconazole gel.

The in vitro and in vivo tolerance of sertaconazole gel, a new topical azole antifungal, was studied. Ketoconazole gel (Panfungol) was used as a reference substance. The methods applied for tolerance assessment were the bovine corneal opacity and permeability test for the in vitro assay and a modified Draize test for the in vivo assay. The results obtained show that both substances can be classified as slightly irritant and with acceptable tolerance. However, unlike ketoconazole gel, sertaconazole gel did not cause a positive lesion index in vivo. Ketoconazole was 5.25 times more irritant in vitro than sertaconazole gel, whose effect was similar to that of saline solution. Consequently, the negligible irritant effect of sertaconazole gel on a type of epithelium that is extremely sensitive, i.e. the cornea, confirms the good tolerance of this new antifungal gel on other structures such as the skin and mucous membranes.