Back to resultsEfficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
Primary Purpose
Myasthenia Gravis, Ocular Myasthenia Gravis
Status
Completed
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Apraclonidine Hcl 0.5% Oph Soln
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring myasthenia gravis, ocular myasthenia, apraclonidine
Eligibility Criteria
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.
Sites / Locations
- American University of Beirut Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in palpebral fissure height (PF)
Change in PF measurements
Change in marginal reflex distance-1 (MRD1)
Change in MRD1 measurements
Change in marginal reflex distance-2 (MRD2)
Change in MRD2 measurements
Change in levator function (LF)
Change in LF measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT05045248
First Posted
August 29, 2021
Last Updated
September 6, 2021
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05045248
Brief Title
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
Official Title
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Ocular Myasthenia Gravis
Keywords
myasthenia gravis, ocular myasthenia, apraclonidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apraclonidine Hcl 0.5% Oph Soln
Other Intervention Name(s)
Iopidine 0.5%
Intervention Description
Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye
Primary Outcome Measure Information:
Title
Change in palpebral fissure height (PF)
Description
Change in PF measurements
Time Frame
Before administration, at 1, 5, 30, and 60 minutes after administration
Title
Change in marginal reflex distance-1 (MRD1)
Description
Change in MRD1 measurements
Time Frame
Before administration, at 1, 5, 30, and 60 minutes after administration
Title
Change in marginal reflex distance-2 (MRD2)
Description
Change in MRD2 measurements
Time Frame
Before administration, at 1, 5, 30, and 60 minutes after administration
Title
Change in levator function (LF)
Description
Change in LF measurements
Time Frame
Before administration, at 1, 5, 30, and 60 minutes after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Salameh, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1107
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
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