Efficacy of Oxymetazoline 0.1% in Acquired Blepharoptosis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Abstract

Purpose: Abnormal eyelid drooping is a defining feature of blepharoptosis, a disorder that can affect the superior vision field. The standard of care is surgical intervention but may be associated with complications. There is emerging evidence that the direct-acting α-adrenergic agonist ophthalmic solution, oxymetazoline, is effective for blepharoptosis. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of oxymetazoline in the management of blepharoptosis.

Patients and methods: A total of five databases were searched. The inclusion was limited only to randomized controlled trials (RCTs) that evaluated the efficacy of oxymetazoline versus placebo. The efficacy endpoint was the mean change in the marginal reflex distance 1 (MRD 1) from baseline. The safety endpoints were mortality and adverse events (AEs). The weighted mean difference (WMD) was implemented for continuous outcomes. For risk of bias assessment, the Revised Cochrane risk of bias tool for randomized trials was used.

Results: 4 RCTs (n = 448) met the eligibility criteria. The meta-analysis yielded a statistically significant higher difference in the WMD in the oxymetazoline group [0.65 mm (95% CI: 0.44 mm to 0.86 mm)] compared to the placebo group [0.26 mm (95% CI: 0.30 mm to 0.48 mm) [p=0.012]. There were no statistically significant differences between the oxymetazoline group [1.2% (95% CI: 0.4-3.6%)] and the placebo group [1.6% (95% CI: 0.5-5.3%), p = 0.73] in terms of serious adverse events.

Conclusion: Oxymetazoline is an effective and safe medication in the management of acquired blepharoptosis.