Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

NCT ID: NCT05167760

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-11-30

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.

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.

Conditions

Synkinesis; Facial Nerve Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Participants will receive the study drug, apraclonidine, per its FDA-approved package labelling

Group Type: EXPERIMENTAL

Apraclonidine

Intervention Type: DRUG

1-2 drops per eye every 8 hours for 2 weeks

Interventions

Apraclonidine

1-2 drops per eye every 8 hours for 2 weeks

Intervention Type: DRUG

Other Intervention Names

Iopidine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Greene

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Greene, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

IRB-300008023

Identifier Type: -

Identifier Source: org_study_id