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Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis

NCT05945615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-09

No results posted yet for this study

Summary

After an episode of facial paralysis, as nerves recover, they aberrantly regenerate and send additional branches to the incorrect muscles in addition to the intended muscle. This leads to what is known as Aberrant Regeneration Syndrome, Post-paralysis Synkinesis, or Nonflaccid Facial Paralysis. It is characterized by poor facial symmetry and function, hypertonic facial muscles at rest, and abnormal facial movements. One sequela is acquired blepharoptosis causing a smaller ocular aperture, visual field obstruction, cosmetic deformity, and abnormal periocular spasms. This study aims to evaluate an FDA approved medication for acquired blepharoptosis due to synkinesis/hyperkinesis as an adjunct to treatment.

Conditions

  • Blepharoptosis
  • Synkinesis
  • Hyperkinesis
  • Facial Paralysis

Interventions

DRUG

Oxymetazoline 0.1% (Pf) Oph Soln Ud

Oxymetazoline was initially developed in 1961. It is a direct sympathomimetic, binding directly to alpha-1 and alpha-2 receptors. Currently, it is used as a nasal decongestant, in the treatment of epistaxis, and as a topical treatment for rosacea. Previously, an ophthalmic formulation was used to treat eye redness and irritation as it is FDA approved for the treatment of acquired blepharoptosis. However, this product line was discontinued when in July of 2020, oxymetazoline received Food and Drug Administration approval for treatment of cosmetic blepharoptosis. In the treatment of blepharoptosis, oxymetazoline acts on the superior tarsal muscle, Müller's muscle, to elevate the eyelid. The superior tarsal muscle is a sympathetically innervated muscle that is partially responsible for elevating the eyelid. Previous cosmetic studies have shown oxymetazoline can serve as an adjunct to botulinum toxin in patients with acquired blepharoptosis.

OTHER

Preservative free lubricating drops

Over the counter ophthalmic lubricating drop.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Jessyka Lighthall, MD · Penn State Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2026-01-08
Completion
2026-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945615 on ClinicalTrials.gov