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Crossover study results favor topical corticosteroid in management of allergic conjunctivitis


Loteprednol etabonate ophthalmic suspension 0.2% and olopatadine HCl ophthalmic solution 0.1% were compared in a study for the treatment of allergic conjunctivitis. After 14 days of use, the topical corticosteroid demonstrated greater efficacy in improving Ocular Surface Disease Index scores and was preferred by a significantly higher proportion of patients. Both medications were safe and well tolerated, and both led to improved signs and symptoms.

Key Points

Fort Lauderdale, FL-Results of a randomized, double-masked, crossover study demonstrate that loteprednol etabonate ophthalmic suspension 0.2% (Alrex, Bausch & Lomb) and olopatadine HCl ophthalmic solution 0.1% (Patanol, Alcon Laboratories) provide equivalent therapeutic value and safety for treating allergic conjunctivitis, although the corticosteroid was favored in patient preference ratings, reported researchers at the annual meeting of the Association for Research in Vision and Ophthalmology.

"This study reaffirms that both of these medications have benefits in the management of allergic conjunctivitis," said John Sheppard, MD, MMSc, an ophthalmologist in private practice in Norfolk, VA. "However, we believe that the preference patients expressed for loteprednol is likely due to a number of formulation-related features, including its glycerin vehicle, suspension preparation, and higher viscosity, as well as to its more potent mechanisms of action for controlling the early, late, cell mediated, and vascular permeability inflammatory pathways involved in allergic reactions."

The study enrolled 60 patients with a diagnosis or history of ocular allergies, allergic conjunctivitis, ocular itching, or conjunctival chemosis. Patients were randomly assigned at baseline to 14 days of twice-daily treatment with either loteprednol or olopatadine. At the end of the study period, patients began a 7-day washout period and then crossed over to a second 14-day treatment period using the alternate medication.

The primary efficacy assessment was based on the validated, 12-item Ocular Surface Disease Index (OSDI) that assesses symptoms of ocular irritation and impact on visual functioning. The OSDI score was recorded at baseline and then on days 14, 21, and 35. There was no significant difference in the mean OSDI at baseline between patients who were initially randomly assigned to loteprednol or olopatadine treatment, 26.6 versus 24.8, respectively. Only loteprednol significantly reduced OSDI in either arm of the crossover study, however.

At the end of the first treatment period, the mean OSDI was reduced significantly to 12.0 (–56%) in the loteprednol group. Patients using olopatadine had a 26% reduction in OSDI score to a mean of 18.2, but the change from baseline was not statistically significant.

On day 21 following the washout period, the mean OSDI score was 15.2 in patients who were to start using loteprednol and 14.1 in the group being switched to olopatadine. After 14 days of treatment, the mean OSDI was reduced further in both groups and was significantly different compared with baseline, although treatment with loteprednol, again, was associated with a greater effect. Mean OSDI at the end of the crossover period was 10.8 in patients switched to loteprednol (–27% from end of washout) and 12.4 (–14% from end of washout) in the olopatadine group.

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