Eyelid Spasm, Tears; Excess
Conditions
Brief summary
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.
Interventions
DRUGBotulinum toxin
15 units of botulinum toxin administered one time to the eye via eye drops
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate * Presence of upper eyelid retraction or asymmetry( \>1mm)
Exclusion criteria
* Adults unable to consent * Individuals less than 18 years of age * Prisoners * Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study. Women who are breast-feeding * Known contradictions or sensitivities to study medication * Grossly abnormal lid margins, anatomical abnormalities * Variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm) * Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters * Presence of an active ocular infection * Inability to sit comfortably for 15 - 30 minutes * Botulinum toxin injection in the eyelids during the past 3 weeks. * Neuromuscular disorders (e.g., Parkinson's disease or myasthenia gravis) * Medication use known to interfere with the effects of botulinum toxin-A within the previous 1 month (e.g., aminoglycoside or benzodiazepines), * Previous history of hypersensitivity reactions to botulinum toxin-A * Dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or Sjogren's syndrome),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Palpebral Fissure Height | baseline and Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining Density | Baseline | 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) 1. (sparse density) 2. (moderate density) 3. (high density and overlapping lesions). |
| Change in Tearing | baseline and Day 3 | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Botulinum Toxin Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 4.2 |
| Palpebral fissure | 11.75 mm STANDARD_DEVIATION 0.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: baseline and Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Group | Change in Palpebral Fissure Height | -0.5 mm | Standard Deviation 0.69 |
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).
Time frame: baseline and Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Group | Change in Tearing | 3 mm | Standard Deviation 5.54 |
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) 1. (sparse density) 2. (moderate density) 3. (high density and overlapping lesions).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Group | Corneal Staining Density | 2 score on a scale | Standard Deviation 0 |
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) 1. (sparse density) 2. (moderate density) 3. (high density and overlapping lesions).
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Group | Corneal Staining Density | 2 score on a scale | Standard Deviation 0 |