Jpn J Ophthalmol. 2026 Apr 10. doi: 10.1007/s10384-026-01340-5. Online ahead of print.
ABSTRACT
PURPOSE: To assess the 6-month efficacy and safety of oxymetazoline hydrochloride ophthalmic solution 0.1% (OMZ 0.1%) versus placebo for acquired blepharoptosis.
STUDY DESIGN: A phase 3, randomized, double-masked, parallel-group, multicenter study conducted in Japan.
METHODS: Patients 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.
RESULTS: Overall, 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.
CONCLUSION: Fourteen 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.
PMID:41961227 | DOI:10.1007/s10384-026-01340-5
