Trial reportBMJ open2026
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.
Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery
A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery
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Abstract
objectiveTo assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery.
designTwo independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies.
settingThe CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA.
participantsPatients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery
interventionsParticipants 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. PRIMARY AND SECONDARY OUTCOME MEASURES: 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.
results426 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.
conclusionsClobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery. TRIAL REGISTRATION NUMBERS: CLOSE-1 (NCT04246801) and CLOSE-2 (NCT04249076).
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