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Completed

NCT Number: NCT05045248

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

American University of Beirut Medical Center

Beirut, 1107, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apraclonidine Hcl 0.5% Oph Soln

Drug

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

Other names: Iopidine 0.5%

Primary outcomes

  1. Change in palpebral fissure height (PF)

    Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration

    Change in PF measurements

  2. Change in marginal reflex distance-1 (MRD1)

    Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration

    Change in MRD1 measurements

  3. Change in marginal reflex distance-2 (MRD2)

    Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration

    Change in MRD2 measurements

  4. Change in levator function (LF)

    Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration

    Change in LF measurements

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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