Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Istanbul University - Cerrahpasa (IUC)

Status and phase: Completed; Phase 4

Conditions: Seborrheic Blepharitis

Treatments: Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate; Drug: Baby shampoo

Study type: Interventional

Funder types: Other

Identifiers

NCT04441528

IRB2021

Details and patient eligibility

About

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.

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 to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).

Enrollment: 48 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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48 participants in 2 patient groups

Lid wipes containing terpinen-4-ol and sodium hyaluronate

Experimental group

Description:

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

Treatment:

Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate

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