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Patient recruitment shortage and study coordinator turnover
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The purpose of this research study is to test if Topical (applied to the surface of the eye) Botulinum Toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin group | Experimental | The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug | 15 units of botulinum toxin administered one time to the eye via eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Palpebral Fissure Height | Palpebral fissure on Day 3 minus palpebral fissure at baseline. Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin. | baseline and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Density | Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
| Baseline |
| Corneal Staining Density |
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Inclusion Criteria:
Exclusion Criteria:
Women who are breast-feeding
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Lee, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33135 | United States |
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For interim analysis of futility, the investigators conducted the study with BT eye drops on first 10 patients and then evaluate the results to see if there are any significant effects. If clinically significant effects are seen, then 34 patients totally (17 in BT vs 17 in saline) are included. The study was terminated and did not continue; therefore, only the first phase of the study was conducted with only one arm (BT eye drops) with results reported for the first phase only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Group | The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Group | The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Palpebral Fissure Height | Palpebral fissure on Day 3 minus palpebral fissure at baseline. Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin. | Posted | Mean | Standard Deviation | mm | baseline and Day 3 | eyes | eyes |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin Group | The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops |
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For interim analysis of futility, the investigators conducted the study with BT eye drops on the first 10 patients and then evaluated the results to see if there were any significant effects. If clinically significant effects are seen, then 34 patients totally (17 in BT vs 17 in saline) are included. The study was terminated and did not continue; therefore, only the first phase of the study was conducted with only one arm (BT eye drops) with results reported for the first phase only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | University of Miami | 305-326-6434 | wlee@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2022 | Jul 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
|
| Day 3 |
| Change in Tearing | Change in tearing will be calculated as tearing on Day 3 minus tearing at baseline. Tearing will be assessed using the Schirmer test with anesthesia. Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The result can range from a minimum of 0 mm (no tearing) to a maximum of 35 mm (maximum tearing). | baseline and Day 3 |
| eyes |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Palpebral fissure | Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin. | Mean | Standard Deviation | mm | eyes |
|
| Participants |
|
| eyes |
|
|
| Secondary | Corneal Staining Density | Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
| Posted | Mean | Standard Deviation | score on a scale | Baseline | eyes | eyes |
|
|
|
| Secondary | Corneal Staining Density | Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
| Posted | Mean | Standard Deviation | score on a scale | Day 3 | eyes | eyes |
|
|
|
| Secondary | Change in Tearing | Change in tearing will be calculated as tearing on Day 3 minus tearing at baseline. Tearing will be assessed using the Schirmer test with anesthesia. Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The result can range from a minimum of 0 mm (no tearing) to a maximum of 35 mm (maximum tearing). | Posted | Mean | Standard Deviation | mm | baseline and Day 3 | eyes | eyes |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |