TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Phase 4

Completed

• Conditions: Seborrheic Blepharitis
• Interventions: Drug: Swabs containing tea tree oil and chamomile oil; Drug: Baby shampoo

• Registration Number: NCT04678531
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-11-12
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-20
• Last Update Submitted: 2020-12-20
• Study First Posted: 2020-12-22
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swabs containing tea tree oil and chamomile oil	Swabs containing tea tree oil and chamomile oil	The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
Baby shampoo	Baby shampoo	Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score	Change from Baseline at 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 Outcome Measures

Name	Time	Method
Efficacy of the treatment assessed by the change in the Schirmer's test results	0-4-8-12 weeks	Dry eye evaluation will be made with Schirmer's 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 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).
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 non-invasive tear breakup time	0-4-8-12 weeks	Dry eye evaluation will be made with non-invasive tear breakup time.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey