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| Name | Class |
|---|---|
| Benign Essential Blepharospasm Research Foundation | OTHER |
| GW Pharmaceuticals Ltd | INDUSTRY |
| Smith-Kettlewell Eye Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - active medication followed by placebo | Active Comparator |
| |
| Group B - placebo followed by active medication | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oral Solution [Epidiolex] | Drug | 100 mg BID for three months Placebo oral solution for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 measurements over 6 months |
| Median Blink Amplitude | Measured in millimeters (mm) | 4 measurements over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Blink Duration | Measured in milliseconds (ms) | 4 measurements over 6 months |
| Median Max Blink Velocity | Measured in millimeters per milliseconds (mm/ms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silkiss Eye Surgery | Oakland | California | 94609 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37606606 | Derived | Silkiss RZ, Koppinger J, Truong T, Gibson D, Tyler C. Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - A Randomized Pilot Study. Transl Vis Sci Technol. 2023 Aug 1;12(8):17. doi: 10.1167/tvst.12.8.17. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2023 | Dec 22, 2023 | 2 |
| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| C535428 | Benign essential blepharospasm |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 4 measurements over 6 months |
| Number of Blinks per 100ms | Total "blinks" in 100 milliseconds (numeric value) | 4 measurements over 6 months |