TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Study Overview
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Brief Summary
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The aim of the study was to compare the efficacy of lid swabs containing tea tree oil (TTO) and chamomile oil and baby shampoo (BS) in the treatment of seborrheic blepharitis.

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 using block randomization to lid wipes containing tea tree oil (TTO) and chamomile oil or baby shampoo (twice daily).

Official Title
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Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial

Conditions
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Seborrheic Blepharitis

Intervention / Treatment
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* Drug: Swabs containing tea tree oil and chamomile oil
* 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: Swabs containing tea tree oil and chamomile oil<br>The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks. | Drug: Swabs containing tea tree oil and chamomile oil<br>* Swabs will be used in 26 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 shampoo will be used in 23 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) | Change from Baseline at 4 weeks | 
| 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) | Change from Baseline at 8 weeks | 
| 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) | Change from Baseline at 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's test results | Dry eye evaluation will be made with Schirmer's 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, tea tree oil, baby shampoo, swabs, chamomile oil