Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

Facial Nerve Palsy Clinical Trial

Official title:

Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05167760
• Other study ID #: IRB-300008023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2023
• Est. completion date: November 2025

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: Benjamin Greene, MD
• Phone: (205) 801-7855
• Email: bgreene[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Nerve Diseases
• Facial Nerve Palsy
• Facial Paralysis
• Synkinesis

Intervention

Drug:
• Apraclonidine
1-2 drops per eye every 8 hours for 2 weeks

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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