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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myasthenia Gravis Ocular Myasthenia Gravis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

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.

Group Type EXPERIMENTAL

Apraclonidine Hcl 0.5% Oph Soln

Intervention Type DRUG

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

Interventions

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Apraclonidine Hcl 0.5% Oph Soln

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

Intervention Type DRUG

Other Intervention Names

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Iopidine 0.5%

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes