Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

The purpose of this study is to determine efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic.

Study Overview

• Status: Withdrawn
• Conditions: Synkinesis; Facial Nerve Palsy
• Intervention / Treatment: Drug: Apraclonidine

Detailed Description

UAB has a large Facial Nerve Clinic that treats patients with acquired facial nerve palsies and the associated difficulties of swallowing/speaking, and visual field defects from ptosis (a drooping or falling of the upper eyelid) and synkinesis (unwanted contractions of the muscles of the face during attempted movement.). Commonly, patients will experience involuntary eyelid contraction with oral movements like smiling. For eyelid synkinesis causing significant aesthetic or functional difficulty, surgery or botox is often the first line treatment. However, not all patients desire this, and some are poor surgical candidates due to other comorbidities. Botox has been shown to work well for these patients, but can be only partially effective. In addition, patients experience a wearing off period between treatments.

Several eye drops are available for the medical treatment of ptosis, including apraclonidine and 0.1% oxymetazoline. Both are alpha 2 adrenergic agonists, which stimulates Mullers muscle, causing muscle contraction and upper eyelid lifting. In addition, apraclonidine has been shown to be beneficial in patients with blepharospasm in a pilot study by Vijayakumar et. al.

We hypothesize that patients with synkinesis, similar to patients with ptosis and blepharospasm, could have symptomatic improvement with apraclonidine use.

Our study will initially be a pilot study, designed similarly to the Vijayakumar study. If this shows improvement for these patients, our hope is to pursue a randomized control trial.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Ability to speak and comprehend English
• Ability to consent for themselves
• Diagnosis of synkinesis affecting eye movement

Exclusion Criteria:

• Age less than 18 years
• Unable to speak and comprehend English
• Unable to consent for themselves
• Diagnosis of congenital ptosis, Horner syndrome, myasthenia travis, mechanical ptosis
• Visual field loss from causes unrelated to facial nerve injury
• Currently receiving monoamine oxidase inhibitors
• Known hypersensitivity to apraclonidine or other components of the drug under study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Participants will receive the study drug, apraclonidine, per its FDA-approved package labelling	Drug: Apraclonidine; 1-2 drops per eye every 8 hours for 2 weeks; Other Names: Iopidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in synkinesis symptoms	A 30 second video clip will be taken prior to administration of the study drug to record the unwanted movements of the facial muscles around the eyes. Approximately 20 minutes after study drug administration, a second 30-second video clip will be taken. Video clips from all of the participants will be pooled together at the end of the study and given to two independent raters. The raters will use the Sunnybrook Facial Grading System to assess each video and rate improvement of synkinesis after administration of the study drug. The Sunnybrook Facial Grading System rates resting symmetry (a scale of 0-2), symmetry of voluntary movement (a scale of 1-5), and synkinesis (a scale of 0-3), and computes a composite score. The higher the composite score, the better - full range of movement is scored as 100 percent.	Baseline - 20 minutes after study drug administration

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Benjamin Greene, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Dyskinesias; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Synkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Apraclonidine
• Other Study ID Numbers: IRB-300008023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No