TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis

December 20, 2020 updated by: Ceyhun Arici, MD, Istanbul University - Cerrahpasa (IUC)

Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Active Comparator: Baby shampoo
Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks
Drug: Baby shampoo
Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Time Frame: Change from Baseline at 4 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)
Change from Baseline at 4 weeks
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Time Frame: Change from Baseline at 8 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)
Change from Baseline at 8 weeks
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Time Frame: 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)
Change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-4-8-12 weeks
Efficacy of the treatment assessed by the change in the Schirmer's test results
Time Frame: 0-4-8-12 weeks
Dry eye evaluation will be made with Schirmer's test.
0-4-8-12 weeks
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.
0-4-8-12 weeks
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).
0-4-8-12 weeks
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.
0-4-8-12 weeks
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.
0-4-8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Koç University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2018

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2021-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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