Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: PURPOSE: To evaluate clobetasol propionate ophthalmic suspension (CPN) as treatment for inflammation and pain after cataract surgery. SETTING: 9 outpatient surgery centers in the United States. DESIGN: Randomized, double-masked, placebo-controlled, dose-selection, 2-part study. METHODS: After 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). 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% 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. CONCLUSIONS: CPN 0.05% twice daily for 3 weeks was safe and reduced ocular inflammation after cataract surgery.
Authors: Jeffrey Levenson, Thomas R. Walters, Joseph Martel, Laurene Wang, Derek J. Nunez
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W4416929195