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Study deems loteprednol etabonate clinically noninferior to prednisolone/fluorometholone
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Loteprednol etabonate was deemed to be clinically noninferior to prednisolone acetate followed by fluorometholone taper as a topical treatment after PRK with respect to haze prevention, IOP elevation and refractive results, according to a study.
Loteprednol etabonate is an ester corticosteroid structurally similar to prednisolone, but with a lower side-effect profile, including a smaller effect on IOP. The aim of the study was to confirm safety with respect to IOP elevation and to test whether the positive effects on haze prevention and recovery of vision were comparable between the two drugs.
A total of 261 eyes of 132 patients undergoing PRK were randomized to a postoperative regimen with either loteprednol etabonate 0.5% gel or prednisolone 1% acetate suspension followed by fluorometholone 0.1% suspension.
No statistically significant difference was found in the rate of postoperative haze, which occurred in 3% of the loteprednol eyes and 5% of the prednisolone/fluorometholone eyes. Clinically significant elevation of IOP was uncommon with either drop and only occurred in eight eyes of four patients, two eyes in the loteprednol arm and six eyes in the prednisolone/fluorometholone arm. The authors specified that “these patients were slightly older than the average patient with a mean age of 42.8 years.”
Visual and refractive results were excellent in both groups, with nearly all eyes achieving uncorrected visual acuity of 20/20 or better at 3 months.
A significantly higher rate of haze formation was observed in prednisolone/fluorometholone eyes when adjunctive mitomycin C (MMC) was used.
“Given the small number of patients who received MMC in our study, it is difficult to draw definitive conclusions from this trend. Eyes with adjunctive MMC after PRK may warrant closer observation of eyes without adjunctive MMC,” the authors noted. – by Michela Cimberle
Disclosures : The authors report no relevant financial disclosures.
Perspective
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John D. Sheppard, MD
This retrospective comparative treatment trial clearly demonstrated equivalence between a more traditional regimen starting with prednisolone and finishing with fluorometholone, and a simpler regimen employing only loteprednol. Complications of elevated IOP or corneal haze were rare in both groups. Refractive results were excellent in both groups.
In clinical practice involving complex patient instructions, monotherapy is preferable. Contrary to a frequent general misconception, loteprednol is a very potent corticosteroid, particularly for ocular surface and corneal applications (Bartlett, 2011). Many clinicians find Loteprednol to be equivalent in these common indications, particularly when compared to generic prednisolone.
Twelve-month follow-up of this cohort warrants an additional communication or publication, particularly with regard to haze seen in the few patients also treated with mitomycin C in this study. A subsequent comparative trial utilizing loteprednol with and without mitomycin C could best guide clinicians treating patients at higher risk of developing postoperative haze, including those with significant ocular surface disease, larger ablation depths for higher degrees of myopia, and older patients. In addition, further directed analysis may demonstrate collateral loteprednol superiority for patients at risk for developing elevated IOP as well as chronic symptomatic dry eye, allergy or meibomitis.
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