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TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

NCT ID: NCT04678531

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2019-11-15

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).

Conditions

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Seborrheic Blepharitis

Keywords

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seborrheic blepharitis tea tree oil baby shampoo swabs chamomile oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Swabs containing tea tree oil and chamomile oil

Intervention Type DRUG

Swabs will be used in 26 patients for 8 weeks and will be discontinued in the following 4 weeks.

Baby shampoo

Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks

Group Type ACTIVE_COMPARATOR

Baby shampoo

Intervention Type DRUG

Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.

Interventions

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Swabs containing tea tree oil and chamomile oil

Swabs will be used in 26 patients for 8 weeks and will be discontinued in the following 4 weeks.

Intervention Type DRUG

Baby shampoo

Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koç University

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Ceyhun Arici, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IRB2021-2

Identifier Type: -

Identifier Source: org_study_id