Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

NCT05167760 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB-300008023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Synkinesis; Facial Nerve Palsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Drug: Apraclonidine

Interventions

Apraclonidine DRUG

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

Also known as: Iopidine

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Synkinesis; Bell Palsy

Interventions

apraclonidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases

Study Officials

• Benjamin Greene, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 22, 2021
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share