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Purpose <p>To assess the 6-month efficacy and safety of oxymetazoline hydrochloride ophthalmic solution 0.1% (OMZ 0.1%) versus placebo for acquired blepharoptosis.</p> Study design <p>A phase 3, randomized, double-masked, parallel-group, multicenter study conducted in Japan.</p> Methods <p>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&#xa0;hours after the morning drop) with OMZ 0.1% QD or BID versus placebo. Adverse events and adverse drug reactions (ADRs) were recorded.</p> Results <p>Overall, baseline MRD-1 (standard deviation) of 336 patients analyzed (n=112 per group) was 1.31 (0.83)&#xa0;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]&#xa0;mm; 95% CI 0.38, 0.79) and OMZ 0.1% BID (0.43 [0.10] mm; 95% CI 0.23, 0.64) (both <i>p</i>&lt;0.05). All ADRs related to the study drug were mild.</p> Conclusion <p>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.</p>

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Six-month efficacy and safety of oxymetazoline hydrochloride 0.1% in Japanese patients with acquired blepharoptosis: a phase 3 study

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  • 发表日期：

    2026年4月10日

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  • Hitoshi Ishikawa,
  • Koji Oka,
  • Hiroshi Inoue

摘要

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.