Back to resultsTTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Primary Purpose
Seborrheic Blepharitis
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Swabs containing tea tree oil and chamomile oil
Baby shampoo
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Blepharitis focused on measuring seborrheic blepharitis, tea tree oil, baby shampoo, swabs, chamomile oil
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Swabs containing tea tree oil and chamomile oil
Baby shampoo
Arm Description
The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks
Outcomes
Primary Outcome Measures
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
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)
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
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)
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
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 Outcome Measures
Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
The number of mites in the epilated 4 eyelashes will be counted under microscope.
Efficacy of the treatment assessed by the change in the Schirmer's test results
Dry eye evaluation will be made with Schirmer's test.
Efficacy of the treatment assessed by the change in the tear breakup time
Dry eye evaluation will be made with tear breakup time.
Efficacy of the treatment assessed by the change in the ocular surface disease index score
OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100).
Efficacy of the treatment assessed by the change in the non-invasive tear breakup time
Dry eye evaluation will be made with non-invasive tear breakup time.
Efficacy of the treatment assessed by the change in the meibomian gland loss
Meibomian gland loss will be evaluated using anterior segment analysis system.
Full Information
NCT ID
NCT04678531
First Posted
December 17, 2020
Last Updated
December 20, 2020
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Koç University
1. Study Identification
Unique Protocol Identification Number
NCT04678531
Brief Title
TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Official Title
Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Koç University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Blepharitis
Keywords
seborrheic blepharitis, tea tree oil, baby shampoo, swabs, chamomile oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Swabs containing tea tree oil and chamomile oil
Arm Type
Experimental
Arm Description
The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
Arm Title
Baby shampoo
Arm Type
Active Comparator
Arm Description
Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks
Intervention Type
Drug
Intervention Name(s)
Swabs containing tea tree oil and chamomile oil
Intervention Description
Swabs will be used in 26 patients for 8 weeks and will be discontinued in the following 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Baby shampoo
Intervention Description
Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.
Primary Outcome Measure Information:
Title
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Description
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)
Time Frame
Change from Baseline at 4 weeks
Title
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Description
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)
Time Frame
Change from Baseline at 8 weeks
Title
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
Description
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)
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
Description
The number of mites in the epilated 4 eyelashes will be counted under microscope.
Time Frame
0-4-8-12 weeks
Title
Efficacy of the treatment assessed by the change in the Schirmer's test results
Description
Dry eye evaluation will be made with Schirmer's test.
Time Frame
0-4-8-12 weeks
Title
Efficacy of the treatment assessed by the change in the tear breakup time
Description
Dry eye evaluation will be made with tear breakup time.
Time Frame
0-4-8-12 weeks
Title
Efficacy of the treatment assessed by the change in the ocular surface disease index score
Description
OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100).
Time Frame
0-4-8-12 weeks
Title
Efficacy of the treatment assessed by the change in the non-invasive tear breakup time
Description
Dry eye evaluation will be made with non-invasive tear breakup time.
Time Frame
0-4-8-12 weeks
Title
Efficacy of the treatment assessed by the change in the meibomian gland loss
Description
Meibomian gland loss will be evaluated using anterior segment analysis system.
Time Frame
0-4-8-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis
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