Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis

NCT05945615 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00022691
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acquired blepharoptosis; hyperkinesis; synkinesis; facial paralysis; aberrant regeneration syndrome; post-paralysis synkinesis; nonflaccid facial paralysis

Outcome Measures

Primary Outcomes (3)

• Difference from baseline to end of study in Sunnybrook Grading Score

  Clinician-graded outcome measure

  6 months

• Difference from baseline to end of study Synkinesis Assessment Questionnaire

  Patient reported outcome measure

  6 months

• Difference from baseline to end of study in Facial Disability Index

  Disease-specific quality of life measure

  6 months

Secondary Outcomes (2)

• Difference in MRD-1 from baseline to when medication is being used

  6 months

• Difference in palpebral height from baseline to when medication is being used

  6 months

Study Arms (2)

Oxymetazoline 0.1% ophthalmic drops

EXPERIMENTAL

Patients will use once daily in affected eye. Drops are provided in single use vials.

Drug: Oxymetazoline 0.1% (Pf) Oph Soln Ud

Preservative free lubricating drops

PLACEBO COMPARATOR

Patients will use once daily in affected eye. Drops are provided in single use vials.

Other: Preservative free lubricating drops

Interventions

Preservative free lubricating drops OTHER

Over the counter ophthalmic lubricating drop.

Also known as: soothe

Preservative free lubricating drops

Oxymetazoline 0.1% (Pf) Oph Soln Ud DRUG

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.

Also known as: Upneeq

Oxymetazoline 0.1% ophthalmic drops

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Primary diagnosis of nonflaccid facial paralysis (aberrant regeneration syndrome) and acquired blepharoptosis.

You may not qualify if:

• Patients under the age of 18
• Patients on cardiac glycosides
• Patients on MAO inhibitors
• Patients with angle closure glaucoma
• Patients who experience asymmetrical eye opening due to weakness (e.g. lagophthalmos).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Blepharoptosis; Synkinesis; Hyperkinesis; Facial Paralysis

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Paralysis

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jessyka Lighthall, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants in the study will be randomized 2:1 to treatment with oxymetazoline 0.1% or the vehicle solution. Randomization schemes were created by a biostatician. This will be stored in a secure database, only accessible to the investigators. Experimental drops and placebo drops will be removed from their labeled boxes and provided to patients with instructions on use.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Facial Plastic and Reconstructive Surgery, Associate Professor, Department of Otolaryngology-Head and Neck Surgery

Model Details: Blinded, randomized, cross-over trial that will analyze and compare the efficacy of oxymetazoline drops alone, oxymetazoline drops adjunct with botulinum toxin, botulinum toxin alone, and no treatment.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: January 11, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)