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Clobetasol Propionate Ophthalmic Suspension to Treat Ocular Inflammation and Pain after Uncomplicated Cataract
Michael S Korenfeld1, Jeffrey Levenson2, Ehsan Sadri3
1Comprehensive Eye Care Ltd., Washington, Missouri.
Purpose:
To evaluate the efficacy and safety of clobetasol propionate ophthalmic suspension (CPN) 0.05% to treat ocular inflammation and pain after cataract surgery.
Design:
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.
Participants:
Patients who underwent uncomplicated cataract surgery.
Methods:
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.
Main Outcome Measures:
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.
Results:
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%.
Conclusions:
CPN 0.05% twice daily for 14 days was safe and rapidly improved inflammation, OP, and visual acuity after cataract surgery.
Financial Disclosures:
Disclosures are in the Footnotes and Disclosures.
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