Seborrheic Blepharitis
Conditions
Keywords
seborrheic blepharitis, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate
Brief summary
The purpose of this study is to investigate the efficacy of lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis compared to baby shampoo.
Detailed description
After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).
Interventions
DRUGLid wipes containing terpinen-4-ol and sodium hyaluronate
Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
DRUGBaby shampoo
Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
Sponsors
Koç University
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of seborrheic blepharitis
Exclusion criteria
* Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions * Patients younger than 18-year-old * Patients who used any treatment for blepharitis within the 6 months prior to the examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score | 0-4-8-12 weeks | BLISS score is calculated according to the answers given to the questionnaire. Higher BLISS scores is related to a worse outcome. (Range is between 0 and 39) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the treatment assessed by the change in the Schirmer test results | 0-4-8-12 weeks | Dry eye evaluation will be made with Schirmer test. |
| Efficacy of the treatment assessed by the change in the tear breakup time | 0-4-8-12 weeks | Dry eye evaluation will be made with tear breakup time. |
| Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy | 0-4-8-12 weeks | The number of mites in the epilated 4 eyelashes will be counted under microscope. |
| Efficacy of the treatment assessed by the change in the non-invasive tear breakup time | 0-4-8-12 weeks | Dry eye evaluation will be made with non-invasive tear breakup time. |
| Efficacy of the treatment assessed by the change in the meibomian gland loss | 0-4-8-12 weeks | Meibomian gland loss will be evaluated using anterior segment analysis system. |
| Efficacy of the treatment assessed by the change in the ocular surface disease index score | 0-4-8-12 weeks | OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100) |
Countries
Turkey (Türkiye)
Outcome results
None listed