Trial reportJapanese journal of ophthalmology2026
Six-month efficacy and safety of oxymetazoline hydrochloride 0.1% in Japanese patients with acquired blepharoptosis: a phase 3 study.
Trial report in Japanese journal of ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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3 authors.
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Abstract
purposeTo assess the 6-month efficacy and safety of oxymetazoline hydrochloride ophthalmic solution 0.1% (OMZ 0.1%) versus placebo for acquired blepharoptosis. STUDY
designA phase 3, randomized, double-masked, parallel-group, multicenter study conducted in Japan.
methodsPatients were randomized 1:1:1 to OMZ 0.1%, once daily (QD) or twice daily (BID), or placebo. Patients received OMZ 0.1% for 6 months. Patients in the placebo group were randomized after 3 months (Treatment Period 1) to OMZ 0.1%, either QD or BID, for the remaining 3 months (Treatment Period 2). The primary efficacy endpoint was the marginal reflex distance-1 (MRD-1) change from baseline to Day 14 (2 hours after the morning drop) with OMZ 0.1% QD or BID versus placebo. Adverse events and adverse drug reactions (ADRs) were recorded.
resultsOverall, baseline MRD-1 (standard deviation) of 336 patients analyzed (n=112 per group) was 1.31 (0.83) mm (Day 0). MRD-1 change from baseline to Day 14 (2 hours after the morning drop) was 1.09 (0.07), 0.93 (0.07), and 0.50 (0.07) mm, with OMZ 0.1% QD, BID, and placebo, respectively. There was a statistically significant difference in the least squares mean (standard error) MRD-1 change versus placebo with OMZ 0.1% QD (0.59 [0.10] mm; 95% CI 0.38, 0.79) and OMZ 0.1% BID (0.43 [0.10] mm; 95% CI 0.23, 0.64) (both p<0.05). All ADRs related to the study drug were mild.
conclusionFourteen days of OMZ 0.1% treatment significantly increased MRD-1 versus placebo. There was no loss of effect after 6 months of treatment and no significant safety concerns.
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