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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05045248
Enrollment
10
Registered
2021-09-16
Start date
2020-06-01
Completion date
2021-04-15
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis, Ocular Myasthenia Gravis

Keywords

myasthenia gravis, ocular myasthenia, apraclonidine

Brief summary

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

Detailed 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.

Interventions

DRUGApraclonidine Hcl 0.5% Oph Soln

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

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in palpebral fissure height (PF)Before administration, at 1, 5, 30, and 60 minutes after administrationChange in PF measurements
Change in marginal reflex distance-1 (MRD1)Before administration, at 1, 5, 30, and 60 minutes after administrationChange in MRD1 measurements
Change in marginal reflex distance-2 (MRD2)Before administration, at 1, 5, 30, and 60 minutes after administrationChange in MRD2 measurements
Change in levator function (LF)Before administration, at 1, 5, 30, and 60 minutes after administrationChange in LF measurements

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026