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Submicron loteprednol etabonate gel 0.38% effective for pain, inflammation management
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Patients treated with a 0.38% submicron formulation of loteprednol etabonate gel after cataract surgery reported less pain and inflammation than those treated with a vehicle-only product.
The double-masked, vehicle-controlled randomized parallel group study included 514 patients who were randomly assigned to one of three treatment groups: 171 patients received loteprednol etabonate gel (Bausch + Lomb) three times a day, 171 patients received loteprednol etabonate gel two times a day, and 172 patients received a vehicle-only product that did not contain loteprednol etabonate.
The primary endpoints of the study were the proportion of patients with grade 0 pain and complete resolution of anterior chamber cells at postoperative day 8.
At postoperative day 8, a significantly greater proportion of patients receiving the gel two or three times a day had complete resolution of anterior chamber cells and no pain compared with the vehicle group; 73.7% of patients in the twice daily gel group and 73.1% of patients in the three times daily gel group experienced no pain compared with 47.7% of patient in the vehicle-only group, while 26.9% of patients in the twice daily gel group and 28.7% of patients in the three times daily gel group experienced complete resolution of anterior chamber cells compared with 9.3% in the vehicle-only group (all P < .001).
“Although topical corticosteroids are widely used to reduce postoperative inflammation and pain, they are associated with potential side effects. These results are very encouraging as they show the efficacy of the submicron loteprednol etabonate ophthalmic gel 0.38% in eliminating ocular inflammation and pain after cataract surgery with a safety profile similar to other loteprednol etabonate formulations,” Fong said in a press release from Bausch + Lomb. – by Robert Linnehan
Disclosures: Fong reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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