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Wirta DL, Korenfeld MS, Foster S, et al. Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials. Clin Ophthalmol. 2021;15:4035-4048doi: 10.2147/OPTH.S322326.
Wirta, D. L., Korenfeld, M. S., Foster, S., Smyth-Medina, R., Bacharach, J., Kannarr, S. R., Jaros, M. J., & Slonim, C. B. (2021). Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials. Clinical ophthalmology (Auckland, N.Z.), 154035-4048. https://doi.org/10.2147/OPTH.S322326
Wirta, David L, et al. "Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials." Clinical ophthalmology (Auckland, N.Z.) vol. 15 (2021): 4035-4048. doi: https://doi.org/10.2147/OPTH.S322326
Wirta DL, Korenfeld MS, Foster S, Smyth-Medina R, Bacharach J, Kannarr SR, Jaros MJ, Slonim CB. Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials. Clin Ophthalmol. 2021 Oct 08;15:4035-4048. doi: 10.2147/OPTH.S322326. eCollection 2021. PMID: 34675472; PMCID: PMC8517985.
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Clin Ophthalmol. 2021 Oct 08;15:4035-4048. doi: 10.2147/OPTH.S322326. eCollection 2021.

Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials.

Clinical ophthalmology (Auckland, N.Z.)

David L Wirta, Michael S Korenfeld, Shane Foster, Robert Smyth-Medina, Jason Bacharach, Shane R Kannarr, Mark J Jaros, Charles B Slonim

Affiliations

  1. Aesthetic Eye Care Institute & Eye Research Foundation, Newport Beach, CA, USA.
  2. Comprehensive Eye Care, Ltd., Washington, MO, USA.
  3. Athens Eye Care, Athens, OH, USA.
  4. North Valley Eye Medical Group, Mission Hills, CA, USA.
  5. North Bay Eye Associates, Petaluma, CA, USA.
  6. Kannarr Eye Care, Pittsburg, KS, USA.
  7. Summit Analytical, Denver, CO, USA.
  8. Department of Ophthalmology, University of South Florida Morsani College of Medicine, Tampa, FL, USA.

PMID: 34675472 PMCID: PMC8517985 DOI: 10.2147/OPTH.S322326

Abstract

PURPOSE: An oxymetazoline 0.1% ophthalmic solution was recently approved for treatment of acquired blepharoptosis in adults. This study's objective was to evaluate the safety profile of oxymetazoline 0.1% when administered once daily for 14-84 days.

PATIENTS AND METHODS: Pooled analysis examined safety outcomes from four randomized, double-masked, placebo-controlled clinical trials conducted at 6, 16, 27, and 35 sites, respectively, in the United States. In total, 568 participants with acquired blepharoptosis were evaluated. Median age was 66 years and 74.8% of participants were female. Overall, 375 participants self-administered oxymetazoline 0.1% to both eyes once/day and 193 self-administered placebo (vehicle) daily. Treatment-emergent adverse event (TEAE) rates, severity, and causality were evaluated in the overall population and within participant subgroups defined based on age, race, and ethnicity. Vital signs and ophthalmic findings were evaluated at predefined study visits. Patient-reported treatment tolerability was recorded at study end.

RESULTS: TEAE incidence was similar among participants using oxymetazoline 0.1% (31.2%) or vehicle (30.6%). Nearly all TEAEs were mild-to-moderate, and most were not suspected of being treatment related. Serious TEAEs occurred in four participants receiving oxymetazoline 0.1% and one participant receiving vehicle. Nine and two participants in the oxymetazoline 0.1% and vehicle groups, respectively, discontinued due to a TEAE. Ocular TEAEs occurring in ≥2% of participants receiving oxymetazoline 0.1% were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, and corneal vital dye staining, with none occurring in >3.5% of participants. TEAE rates were similar across subgroups based on age, race, and ethnicity. No clinically significant mean changes in vital signs or ophthalmologic findings occurred, and >98% of participants rated oxymetazoline 0.1% as causing no/mild discomfort.

CONCLUSION: Once-daily oxymetazoline 0.1% was safe and well tolerated in participants with acquired blepharoptosis when used for 14-84 days. Safety did not appear to differ based on age, race, or ethnicity.

© 2021 Wirta et al.

Keywords: Müller’s muscle; adrenergic agonist; adverse event; eye drop; intraocular pressure; pupil; topical

Conflict of interest statement

DL Wirta reports research support from RVL Pharmaceuticals, Inc., and Osmotica Pharmaceuticals. MS Korenfeld reports consultant fees from Osmotica Pharmaceuticals and RVL Pharmaceuticals, Inc. S Foste

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