Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicentre, randomised, placebo-controlled, double-masked clinical studies.

Abstract

To assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery. Two independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies. The CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA. Patients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery INTERVENTIONS: Participants were randomised to either clobetasol or placebo four times a day for 14 days. Follow-up visits occurred on days 3, 8, 15 and 29. The primary endpoint was the proportion of patients with anterior chamber cell (ACC) grade 0 on day 8. A key secondary efficacy endpoint was the proportion of patients with a Visual Analogue Scale (VAS) pain score of 0 on day 8. Safety was also assessed. 426 patients were randomised: 281 to the clobetasol arm and 145 to the placebo arm. The proportion of patients with ACC of 0 at day 8 was significantly superior with clobetasol (37.8% vs 18.1%; odds ratio [OR] 2.8; p<0.0001). The percentage of patients with a VAS pain score of 0 on day 8 was greater with clobetasol (54.7% vs 36.5%; OR 2.1; p=0.0005). Related treatment-emergent adverse events were reported in 3.9% of patients on clobetasol and 5.5% on placebo. Clobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery. CLOSE-1 (NCT04246801) and CLOSE-2 (NCT04249076).