Trial reportJournal of cataract and refractive surgery2026
Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery.
Trial report in Journal of cataract and refractive surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
5 authors.
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Abstract
purposeTo evaluate clobetasol propionate ophthalmic suspension (CPN) as treatment for inflammation and pain after cataract surgery.
setting9 outpatient surgery centers in the United States.
designRandomized, double-masked, placebo-controlled, dose-selection, 2-part study.
methodsAfter uneventful cataract surgery, participants were randomized to CPN 0.05% or placebo (1:1) twice daily for 21 days (part A), or CPN 0.05%, CPN 0.1%, or their corresponding placebos (1:1:1:1) twice daily for 3 days, then once daily for 11 days (part B). Primary efficacy endpoints were anterior chamber cell (ACC) count and ocular pain grade; secondary endpoints included visual acuity, anterior chamber flare (ACF) grade, and number of participants rescued. Safety assessments included adverse events, ophthalmoscopy assessments, and intraocular pressure (IOP).
resultsIn part A, 45 participants were randomized (mean age 67.7 years; 71.1% female). In part B, 87 participants were randomized (mean age 68.0 years; 63.2% female). CPN 0.05% twice daily for 21 days (part A) produced statistically significant reductions of ACC count and ACF grade compared with placebo, with similar results after only 14 days of dosing. The CPN twice daily/once daily regimens (part B) were less efficacious than 0.05% twice daily. No participants on CPN were rescued. CPN was well tolerated, with an adverse event profile similar to placebo, including no meaningful IOP increases during up to 21 days of dosing.
conclusionsCPN 0.05% twice daily for 3 weeks was safe and reduced ocular inflammation after cataract surgery.
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