None listed
Conditions
Brief summary
We aim to evaluate safety and efficacy of using various dosage of neostigmine as an ophthalmic administration for diagnosing myasthenia gravis. The first cohort of patients will be instilled with a starting dose of neostigmine solution which will be determined by the preclinical animal models, and the next cohort will receive the higher dose level of neostigmine in a stepwise pattern. We hypothesized that topical neostigmine is safe and can increase vertical palpebral fissure in myasthenia gravis patients presenting with ptosis.
Interventions
Participants will receive neostigmine solution delivered as eye drops. Each participants will be received only one of four dose level (1 drop of 1 mg/ml; 1 drop of 1.5 mg/ml; 1 drop of 2.5 mg/ml; 2 drops of 2.5 mg/ml) and only one time on day 1. There will be different cohorts for each dose level. Single instillation of eye drops will be administered into the symptomatic eye or the eye with more severe ptosis in patients with bilateral ptosis. The instillation will be performed by an ophthalm
Participants will receive neostigmine solution delivered as eye drops. Each participants will be received only one of four dose level (1 drop of 1 mg/ml; 1 drop of 1.5 mg/ml; 1 drop of 2.5 mg/ml; 2 drops of 2.5 mg/ml) and only one time on day 1. There will be different cohorts for each dose level. Single instillation of eye drops will be administered into the symptomatic eye or the eye with more severe ptosis in patients with bilateral ptosis. The instillation will be performed by an ophthalmologist at the ophthalmology clinic.
Sponsors
Faculty of Medicine, Chulalongkorn University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or older who presented with ptosis and were diagnosed with myasthenia gravis by neuro-ophthalmologists or neurologists in the King Chulalongkorn Memorial Hospital
Exclusion criteria
Patients with generalized myasthenia gravis currently requiring medications, ocular myasthenia gravis currently requiring immunosuppressants, aponeurotic ptosis, mechanical ptosis, traumatic ptosis, other diseases of myogenic or neurogenic ptosis, ophthalmic diseases requiring ophthalmic drops except lubrications, history of eyelid surgery or trauma, patients who had abnormal movement of the eyelids that interfere with the evaluation of the test e.g., eyelid myokymia, facial tics, blepharospasm, and facial spasm, history of neostigmine allergy, or contraindication to neostigmine.
Outcome results
None listed