A Phase 3 clinical trial compared clobetasol propionate eye drops to a placebo in patients who had inflammation after routine cataract surgery. The study included 426 patients across 19 and 17 sites in the USA. Participants received either the active medication or the placebo four times a day for 14 days. Researchers measured eye inflammation and pain levels at several points, including day 8 and day 29.
On day 8, 37.8% of patients using clobetasol had no visible inflammation in the eye, compared to 18.1% of those using the placebo. Additionally, 54.7% of the clobetasol group reported no pain, versus 36.5% in the placebo group. The differences were statistically significant.
Safety data showed that 3.9% of patients on clobetasol experienced adverse events, while 5.5% of those on the placebo did. No serious adverse events were reported, and no patients stopped the treatment due to side effects. This study suggests clobetasol may help manage inflammation and pain more effectively than a placebo in this specific setting.