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

Phase 2

Completed

• Conditions: Myasthenia Gravis; Ocular Myasthenia Gravis
• Interventions: Drug: Apraclonidine Hcl 0.5% Oph Soln

• Registration Number: NCT05045248
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Study First Submitted: 2021-08-29
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Apraclonidine Hcl 0.5% Oph Soln	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon