Clinical efficacy of Fluorometholone versus Loteprednol eye drops after photorefractive keratectomy: A triple-blinded randomized controlled trial.

Abstract

This study aimed to compare the anti-inflammatory efficacy and safety of 0.1% Fluorometholone (FML) versus (vs.) 0.5% Loteprednol etabonate (LE) following photorefractive keratectomy (PRK). A triple-blinded randomized controlled trial was conducted on both eyes of 100 patients with stable refraction who were candidates for PRK. Both eyes in each subject were randomly allocated to the FML or LE groups. The product to be tested was 0.1% FML eye drops packaged in droppers vs. the 0.5% LE sterile ophthalmic suspension (Lotemax®) packaged in identical droppers. The main clinical outcomes were changes in best-corrected distance visual acuity (BCDVA) and corneal optical density. The second clinical outcomes were a change in intraocular pressure (IOP) after the intervention. There was no significant difference regarding mean corneal optical density changes between the two groups, one (P = 0.55) and three months (P = 0.98) after the intervention. The mean ± SD BCDVA after one month of the intervention was 0.79 ± 0.11 and 0.84 ± 0.11 in LE and FML groups, retrospectively (P = 0.02). There was no significant difference regarding mean BCDVA between the two groups three months after intervention (P = 0.21). The IOP showed no significant difference between the two groups after one (P = 0.18) and three months (P = 0.53) of the intervention. The results of this clinical trial demonstrate that LE and FML treatment was effective with no clinically meaningful effect on IOP following a short course of treatment.