Efficacy and safety of short-duration topical treatment with azithromycin oil-based eyedrops in an experimental model of corneal refractive surgery.

PURPOSE: To assess the tolerance and side effects of azithromycin eyedrops at the ocular surface after corneal refractive surgery in an experimental animal model.

METHODS: The effect of azithromycin eyedrops was evaluated in hen corneas that underwent laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) surgery in 1 eye, using the fellow eye (not manipulated) as a control. Animals were treated bid 3 days prior to surgery and 3 days after surgery with T1225 1.5% azithromycin eyedrops or saline eyedrops (balanced salt solution), or were left untreated as a control. Clinical course and cell biology (apoptosis, proliferation, and differentiation) measurements were assessed.

RESULTS: Infections were present in the following proportions of corneas operated on by LASIK: 0% treated with azithromycin, 60% treated with BSS, and 30% untreated. No corneal abscess or keratitis were present in any PRK or unmanipulated corneas. Conjunctival edema and redness were less prevalent in LASIK-operated eyes treated with azithromycin than in BSS-treated or untreated eyes and were not observed in any PRK or unmanipulated corneas. In PRK-operated eyes treated with azithromycin, a decrease was observed in the apoptosis and an increase in the stromal proliferation. There were no differences in these parameters for LASIK and unmanipulated eyes.

CONCLUSIONS: Topical administration of T1225 oil-based azithromycin eyedrops was well tolerated in both unmanipulated hen corneas and those treated with corneal refractive surgery (PRK and LASIK). T1225 demonstrated a potent antibiotic effect after LASIK treatment.