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Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure
Phase 4 trial testing Botulinum toxin in Tears; Excess in 2 participants. Terminated before completion.
| Lead sponsor | University of Miami |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 29 November 2022 |
| Primary completion | 28 July 2024 |
| Estimated completion | 28 July 2024 |
| Sites | 1 location across United States |
University of Miami
18 and older, any sex, with Tears; Excess or Eyelid Spasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Botulinum Toxin Group | -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).
| Group | Value | 95% CI |
|---|---|---|
| Botulinum Toxin Group | 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).
| Group | Value | 95% CI |
|---|---|---|
| Botulinum Toxin Group | 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).
| Group | Value | 95% CI |
|---|---|---|
| Botulinum Toxin Group | 3 | ± 5.54 |
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.
No peer-reviewed publications indexed yet for this trial.
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