Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

NCT04441528 | Completed Phase 4

• 1 other identifier: IRB2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Blepharitis

Keywords

seborrheic blepharitis; terpinen-4-ol; baby shampoo; lid wipes; sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy

  0-4-8-12 weeks

• Efficacy of the treatment assessed by the change in the Schirmer test results

  0-4-8-12 weeks

• Efficacy of the treatment assessed by the change in the tear breakup time

  0-4-8-12 weeks

• Efficacy of the treatment assessed by the change in the ocular surface disease index score

  0-4-8-12 weeks

• Efficacy of the treatment assessed by the change in the non-invasive tear breakup time

  0-4-8-12 weeks

Study Arms (2)

Lid wipes containing terpinen-4-ol and sodium hyaluronate

EXPERIMENTAL

The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.

Drug: Lid wipes containing terpinen-4-ol and sodium hyaluronate

Baby shampoo

ACTIVE COMPARATOR

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

Interventions

Lid wipes containing terpinen-4-ol and sodium hyaluronate DRUG

Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.

Lid wipes containing terpinen-4-ol and sodium hyaluronate

Baby shampoo DRUG

Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.

Baby shampoo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of seborrheic blepharitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Koç University: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

TU (1)