Back to resultsLid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Primary Purpose
Seborrheic Blepharitis
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Lid wipes containing terpinen-4-ol and sodium hyaluronate
Baby shampoo
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Blepharitis focused on measuring seborrheic blepharitis, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate
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
Lid wipes containing terpinen-4-ol and sodium hyaluronate
Baby shampoo
Arm Description
The lid wipes 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)
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 test results
Dry eye evaluation will be made with Schirmer 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
NCT04441528
First Posted
June 18, 2020
Last Updated
June 18, 2020
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Koç University
1. Study Identification
Unique Protocol Identification Number
NCT04441528
Brief Title
Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Official Title
Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 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 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.
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 to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) 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, terpinen-4-ol, baby shampoo, lid wipes, sodium hyaluronate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lid wipes containing terpinen-4-ol and sodium hyaluronate
Arm Type
Experimental
Arm Description
The lid wipes 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)
Lid wipes containing terpinen-4-ol and sodium hyaluronate
Intervention Description
Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Baby shampoo
Intervention Description
Baby will be used in 24 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
0-4-8-12 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 test results
Description
Dry eye evaluation will be made with Schirmer 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
Learn more about this trial
Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
We'll reach out to this number within 24 hrs