TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Istanbul University - Cerrahpasa (IUC)

Status and phase: Completed; Phase 4

Conditions: Seborrheic Blepharitis

Treatments: Drug: Baby shampoo; Drug: Swabs containing tea tree oil and chamomile oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04678531

IRB2021-2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups

Swabs containing tea tree oil and chamomile oil

Experimental group

Description:

The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.

Treatment:

Drug: Swabs containing tea tree oil and chamomile oil

Baby shampoo

Active Comparator group

Description:

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

Treatment:

Drug: Baby shampoo