A Phase 2/3 interventional study of Cannabidiol Oral Solution [Epidiolex] in Blepharospasm, Blepharospasm, Benign Essential and CBD, sponsored by Silkiss Eye Surgery. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Silkiss Eye Surgery · Phase 2/3, Interventional, and Treatment
The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
Exclusion Criteria:
Drug: Cannabidiol Oral Solution [Epidiolex]
Drug: Cannabidiol Oral Solution [Epidiolex]
100 mg BID for three months Placebo oral solution for three months
Eyeblink analysis from high speed videocamera recordings - see separate outcome measures
All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB.
Time frame: 4 measurements over 6 months
Median Blink Amplitude
Measured in millimeters (mm)
Time frame: 4 measurements over 6 months
Median Blink Duration
Measured in milliseconds (ms)
Time frame: 4 measurements over 6 months
Median Max Blink Velocity
Measured in millimeters per milliseconds (mm/ms)
Time frame: 4 measurements over 6 months
Number of Blinks per 100ms
Total "blinks" in 100 milliseconds (numeric value)
Time frame: 4 measurements over 6 months
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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