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Completed

NCT Number: NCT04441528

Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

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.

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Key information

Conditions

Seborrheic Blepharitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lid wipes containing terpinen-4-ol and sodium hyaluronate

Drug

Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.

Baby shampoo

Drug

Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.

Primary outcomes

  1. Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score

    Time frame: 0-4-8-12 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 outcomes

  1. Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy

    Time frame: 0-4-8-12 weeks

    The number of mites in the epilated 4 eyelashes will be counted under microscope.

  2. Efficacy of the treatment assessed by the change in the Schirmer test results

    Time frame: 0-4-8-12 weeks

    Dry eye evaluation will be made with Schirmer test.

  3. Efficacy of the treatment assessed by the change in the tear breakup time

    Time frame: 0-4-8-12 weeks

    Dry eye evaluation will be made with tear breakup time.

  4. Efficacy of the treatment assessed by the change in the ocular surface disease index score

    Time frame: 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)

  5. Efficacy of the treatment assessed by the change in the non-invasive tear breakup time

    Time frame: 0-4-8-12 weeks

    Dry eye evaluation will be made with non-invasive tear breakup time.

  6. Efficacy of the treatment assessed by the change in the meibomian gland loss

    Time frame: 0-4-8-12 weeks

    Meibomian gland loss will be evaluated using anterior segment analysis system.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Koç University

Registry information

Official study title

Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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