Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05167760

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Synkinesis Facial Nerve Palsy	Drug: Apraclonidine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement in synkinesis symptoms [Baseline - 20 minutes after study drug administration]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Greene, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05167760

Other Study ID Numbers:

IRB-300008023

First Posted:

Dec 22, 2021

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bell Palsy

Facial Paralysis

Facial Nerve Diseases

Synkinesis

Apraclonidine

Study Results

No Results Posted as of Jun 9, 2022