Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery.

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.