Clinical trial NCT05167760: Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
Official title: Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Synkinesis
Facial Nerve Palsy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in synkinesis symptoms
timeFrame: Baseline - 20 minutes after study drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Benjamin Greene, MD
role: PRINCIPAL_INVESTIGATOR
References: