Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis
June 18, 2020 updated by: Ceyhun Arici, MD, Istanbul University - Cerrahpasa (IUC)
Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic 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.
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 to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).
Study Type
Interventional
Enrollment (Actual)
48
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
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-
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Istanbul, Turkey
- Istanbul University-Cerrahpaşa
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-
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
18 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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Lid wipes containing terpinen-4-ol and sodium hyaluronate
The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
|
Lid wipes will be used in 24 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.
|
Baby will be used in 24 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: 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)
|
0-4-8-12 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 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 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
|
|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 1, 2018
Primary Completion (ACTUAL)
November 1, 2019
Study Completion (ACTUAL)
November 1, 2019
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2020
Last Update Submitted That Met QC Criteria
June 18, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2021
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.