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

American University of Beirut Medical Center

Status and phase: Completed; Phase 2

Conditions: Myasthenia Gravis; Ocular Myasthenia Gravis

Treatments: Drug: Apraclonidine Hcl 0.5% Oph Soln

Study type: Interventional

Funder types: Other

Identifiers

NCT05045248

BIO-2019-0027

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patients

Experimental group

Description:

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.

Treatment:

Drug: Apraclonidine Hcl 0.5% Oph Soln