Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis

NCT05045248 | Completed Phase 2 FDA Drug

• 1 other identifier: BIO-2019-0027
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.

Conditions

Myasthenia Gravis; Ocular Myasthenia Gravis

Keywords

myasthenia gravis; ocular myasthenia; apraclonidine

Outcome Measures

Primary Outcomes (4)

• Change in palpebral fissure height (PF)

  Change in PF measurements

  Before administration, at 1, 5, 30, and 60 minutes after administration

• Change in marginal reflex distance-1 (MRD1)

  Change in MRD1 measurements

  Before administration, at 1, 5, 30, and 60 minutes after administration

• Change in marginal reflex distance-2 (MRD2)

  Change in MRD2 measurements

  Before administration, at 1, 5, 30, and 60 minutes after administration

• Change in levator function (LF)

  Change in LF measurements

  Before administration, at 1, 5, 30, and 60 minutes after administration

Study Arms (1)

Patients

EXPERIMENTAL

Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis.

Drug: Apraclonidine Hcl 0.5% Oph Soln

Interventions

Apraclonidine Hcl 0.5% Oph Soln DRUG

Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye

Also known as: Iopidine 0.5%

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.

You may not qualify if:

• Patients receiving mono-amino-oxidase inhibitors.
• Patients with history of hypertension, cardiac, or cerebrovascular disease.
• Women with confirmed pregnancy.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, 1107, Lebanon

Location

Related Publications (1)

• Agha M, Ismail H, Sawaya R, Salameh J. Efficacy of apraclonidine eye drops in treating ptosis secondary to myasthenia gravis: A pilot clinical trial. Muscle Nerve. 2023 Aug;68(2):206-210. doi: 10.1002/mus.27851. Epub 2023 May 31.

  PMID: 37259693 DERIVED

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

apraclonidine

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Johnny Salameh, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Neurology

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 16, 2021
• Study Start: June 1, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)