J Cataract Refract Surg. 2025 Nov 26. doi: 10.1097/j.jcrs.0000000000001845. Online ahead of print.
ABSTRACT
PURPOSE: To evaluate clobetasol propionate ophthalmic suspension (CPN) as treatment for inflammation and pain after cataract surgery.
SETTING: Nine outpatient surgery centers in the USA.
DESIGN: A randomized, double-masked, placebo-controlled, dose-selection, two-part study.
METHODS: After uncomplicated cataract surgery, participants were randomized to CPN 0.05% or placebo (1:1) twice daily (BID) for 21 days (Part A), or CPN 0.05%, CPN 0.1%, or their corresponding placebos (1:1:1:1) BID for 3 days, then once daily (QD) 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).
RESULTS: In 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% BID for 21 days (Part A) produced statistically significant reductions of ACC count and ACF grade compared to placebo, with similar results after only 14 days of dosing. The CPN BID/QD regimens (Part B) were less efficacious than 0.05% BID. 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.
CONCLUSIONS: CPN 0.05% BID for 3 weeks was safe and reduced ocular inflammation after cataract surgery.
TRANSLATIONAL RELEVANCE: CPN 0.05% administered twice a day has the potential to be a safe and effective treatment for inflammation after cataract surgery.
PMID:41329923 | DOI:10.1097/j.jcrs.0000000000001845
