Hemifacial Spasm Patients Hemifacial spasm, dry eye disease, Botulinum toxin, Diquafosol eye drop, Hyaluronic acid eye drop
Conditions
Interventions
Patients receive 3% Diquafosol eye drop six times daily for 12 weeks, followed by a 4-week washout period, then 0.3% Hyaluronic Acid eye drop six times daily (in order to blind the participant and min
Active Comparator Drug,Active Comparator Drug
Group A (start with 3% Diquafosol eye drop),Group B (start with 0.3% Hyaluronic Acid eye drop)
Sponsors
Akarawit Eiamsamarng
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with Hemifacial Spasm with dry eye disease, who are currently receiving treatment at the Botoxin Clinic, Ophthalmology Outpatient Department, Siriraj Hospital, and have undergone at least three consecutive sessions of Onabotulinum toxin A injection, administered every 16 weeks using a fixed and individualized dosage regimen, will be enrolled. In addition, eligible participants must not have used any topical ophthalmic eye drops for at least 4 weeks (1 month) prior to enrollment. All participants must have provided written informed consent voluntarily prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Presence of active ocular surface disease or other anterior segment conditions, 2. History of ocular trauma or surgery involving the eyelids or eyes within the past 6 months prior to enrollment, 3. Current use of contact lenses, 4. Known history of allergy to any of the investigational eye drops, 5. Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemifacial Spasm Severity 28 weeks Samsung Medical Center (SMC) Grading Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical signs and symptoms of dry eye disease 28 weeks Ocular surface staining, Ocular Surface Disease Index (OSDI) questionnaire,Tear film stability 28 weeks Tear Meniscus Height, Tear Break-Up Time ,Quality of life 28 weeks Dry Eye-Related Quality-of-Life Score, Patient satisfaction,Safety and tolerability 28 weeks Recording of adverse events and side effects | — |
Countries
Thailand
Contacts
Public ContactAkarawit Eiamsamarng
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed