Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

Seborrheic Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441528
• Other study ID #: IRB2021
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: June 2020
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Seborrheic Blepharitis

Intervention

Drug:
• Lid wipes containing terpinen-4-ol and sodium hyaluronate
Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
• Baby shampoo
Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	0-4-8-12 weeks
Secondary	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.	0-4-8-12 weeks
Secondary	Efficacy of the treatment assessed by the change in the Schirmer test results	Dry eye evaluation will be made with Schirmer test.	0-4-8-12 weeks
Secondary	Efficacy of the treatment assessed by the change in the tear breakup time	Dry eye evaluation will be made with tear breakup time.	0-4-8-12 weeks
Secondary	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)	0-4-8-12 weeks
Secondary	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.	0-4-8-12 weeks
Secondary	Efficacy of the treatment assessed by the change in the meibomian gland loss	Meibomian gland loss will be evaluated using anterior segment analysis system.	0-4-8-12 weeks