Clobetasol Propionate Ophthalmic Suspension to Treat Ocular Inflammation and Pain after Uncomplicated Cataract Surgery.

Abstract

To evaluate the efficacy and safety of clobetasol propionate ophthalmic suspension (CPN) 0.05% to treat ocular inflammation and pain after cataract surgery. Two multicenter, randomized, double-masked, placebo-controlled phase 3 trials, identical in design except for a corneal endothelial cell (EC) safety substudy in the second trial. Patients who underwent uncomplicated cataract surgery. After surgery, participants were randomized 1:1 to CPN 0.05% or placebo 1 drop twice daily for 14 days instilled into the operated eye. Efficacy outcomes were: (1) the percentage of participants with anterior chamber cell (ACC) count of 0 at postoperative day (POD) 8, maintained through POD 15; (2) the percentage of participants with ocular pain (OP) grade of 0 at POD 4, maintained through POD 15; and (3) inflammation, OP grade, and visual acuity at PODs 4, 8, 15, and 22. Safety outcomes were adverse event reports, ophthalmoscopy, intraocular pressure (IOP), and EC assessments. Seven hundred forty-eight participants were randomized to receive CPN 0.05% (n = 366) or placebo (n = 382). The demographic and baseline characteristics were well balanced between the 2 groups. CPN 0.05% met the primary end points, producing rapid and sustained clearance of inflammation and absence of OP that was statistically significantly greater than placebo. At POD 15, 58.2% of participants receiving CPN 0.05% and 17.3% of participants receiving placebo had an ACC count of 0 (P < 0.001), and 88.5% of participants receiving CPN 0.05% and 45.8% of participants receiving placebo had an OP grade of 0 (P < 0.001). By POD 4, visual acuity had improved more rapidly in the CPN 0.05% group than in the placebo group (P < 0.001). No rebound of the efficacy parameters was noted on POD 22 after CPN 0.05% was stopped for 1 week. More participants receiving placebo than receiving CPN 0.05% required rescue medications (P < 0.001). CPN 0.05% was well tolerated, with a safety profile similar to that of the placebo. No meaningful IOP increases or corneal EC changes occurred in the group receiving CPN 0.05%. CPN 0.05% twice daily for 14 days was safe and rapidly improved inflammation, OP, and visual acuity after cataract surgery. Disclosures are in the Footnotes and Disclosures.