A Phase 4 interventional study of Botulinum toxin in Tears; Excess and Eyelid Spasm, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 2 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women who are breast-feeding
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes.
Drug: Botulinum toxin
15 units of botulinum toxin administered one time to the eye via eye drops
Also known as: BOTOX
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
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
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
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
| Milestone | Botulinum Toxin Group |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
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.
| mm | Botulinum Toxin Group |
|---|---|
| Change in Palpebral Fissure Height | -0.5 ± 0.69 |
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).
| score on a scale | Botulinum Toxin Group |
|---|---|
| Corneal Staining Density | 2 ± 0 |
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).
| score on a scale | Botulinum Toxin Group |
|---|---|
| Corneal Staining Density | 2 ± 0 |
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).
| mm | Botulinum Toxin Group |
|---|---|
| Change in Tearing | 3 ± 5.54 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Botulinum Toxin Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Botulinum Toxin Group |
|---|---|
| Mean | 57 ± 4.2 |
| Sex: Female, Male(Participants) | Botulinum Toxin Group |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Botulinum Toxin Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Palpebral fissure(mm) | Botulinum Toxin Group |
|---|---|
| Mean | 11.75 ± 0.42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum Toxins