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

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045248
• Other study ID #: BIO-2019-0027
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: September 2021
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients receiving mono-amino-oxidase inhibitors.

• Patients with history of hypertension, cardiac, or cerebrovascular disease.

• Women with confirmed pregnancy.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis
• Ocular Myasthenia Gravis

Intervention

Drug:
• Apraclonidine Hcl 0.5% Oph Soln
Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in palpebral fissure height (PF)	Change in PF measurements	Before administration, at 1, 5, 30, and 60 minutes after administration
Primary	Change in marginal reflex distance-1 (MRD1)	Change in MRD1 measurements	Before administration, at 1, 5, 30, and 60 minutes after administration
Primary	Change in marginal reflex distance-2 (MRD2)	Change in MRD2 measurements	Before administration, at 1, 5, 30, and 60 minutes after administration
Primary	Change in levator function (LF)	Change in LF measurements	Before administration, at 1, 5, 30, and 60 minutes after administration