Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis

Conditions
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Seborrheic Blepharitis

Intervention / Treatment
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* Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate
* Drug: Baby shampoo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lid wipes containing terpinen-4-ol and sodium hyaluronate<br>The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. | Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate<br>* Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.<br>|
| Active Comparator: Baby shampoo<br>Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. | Drug: Baby shampoo<br>* Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score | 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) | 0-4-8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy | The number of mites in the epilated 4 eyelashes will be counted under microscope. | 0-4-8-12 weeks | 
| Efficacy of the treatment assessed by the change in the Schirmer test results | Dry eye evaluation will be made with Schirmer test. | 0-4-8-12 weeks | 
| Efficacy of the treatment assessed by the change in the tear breakup time | Dry eye evaluation will be made with tear breakup time. | 0-4-8-12 weeks | 
| Efficacy of the treatment assessed by the change in the ocular surface disease index score | OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100) | 0-4-8-12 weeks | 
| Efficacy of the treatment assessed by the change in the non-invasive tear breakup time | Dry eye evaluation will be made with non-invasive tear breakup time. | 0-4-8-12 weeks | 
| Efficacy of the treatment assessed by the change in the meibomian gland loss | Meibomian gland loss will be evaluated using anterior segment analysis system. | 0-4-8-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seborrheic blepharitis, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate