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Topical Botulinum Toxin for Eyelid Retraction and Tearing
NCT06080438Phase 4
Key facts
- Status
- Terminated
- Start
- Nov 2022
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- University of Miami
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- Eyelid Retraction
01
Overview
Phase 4, open-label, single-arm trial of botulinum toxin type A in Eyelid Retraction, sponsored by University of Miami. Primary endpoint: Change in Palpebral Fissure Height at Day 3. Started Nov 2022; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Botulinum toxin group
Participants receive botulinum toxin eye drops in the left eye.
03
Who it enrols
Adults with upper eyelid retraction or asymmetry (>1mm), excluding those with active ocular infection, neuromuscular disorders (e.g., myasthenia gravis), or recent botulinum toxin injections.
04
Endpoints
Primary
Change in Palpebral Fissure Height
Secondary
Corneal Staining Density
Change in Tearing
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