Effectiveness of 0.3% Hyaluronic Acid Eye Drops in the Treatment of Benign Essential Blepharospasm and Hemifacial Spasm

Phase 4

Completed

• Conditions: patients with benign essential blepharospasm (BEB) or hemifacial spasm (HFS) during concurrent treatment with botulinum toxin type A (BoNT-A) injection; benign essential blepharospasm; hemifacial spasm; dry eye disease; 0.3% hyaluronic acid; botulinum toxin

• Registration Number: TCTR20220423002
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Brief Summary

After 3 months of treatment with 0.3% HA eye drops, patients with BEB and HSF experienced significant improvements in spasm score (p 0.030, p 0.013), TBUT (p 0.001, p 0.010), and mean corneal fluorescein staining grade (p 0.005, p 0.020). They also reported a significant improvement in the mean subjective dry eye symptom questionnaire score (p 0.010, p 0.007). All parameters in no intervention arm were not significantly changed.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-01
• Study Start: 2022-04-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

All patients with the diagnosis of BEB or HFS who were concurrently treated with BoNT-A injections, regardless of dry eye symptoms, and willing to enroll in the study.

Exclusion Criteria

1. neurological abnormalities other than craniocervical dystonia
2. features suggestive of secondary dystonias
3. history of other active ocular surface disorders or anterior segment diseases
4. ocular trauma or eyelid/ocular surgery in the preceding 6 months
5. contact lens wear
6. concurrent application of any type(s) of artificial tears or other treatments for DED in the preceding 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in spasm severity 3 months after instillation of eye drops Blepharospasm Severity Scale (BSS) score in patients with BEB; Samsung Medical Class (SMC) Grading Scale score in patients with HFS

Secondary Outcome Measures

Name	Time	Method
Changes in dry eye parameters 3 months after instillation of eye drops dry eye symptoms, lower lid tear meniscus height, tear break-up time, and corneal fluorescein stain in all patients