NCT04678531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 17, 2020

Last Update Submit

December 20, 2020

Conditions

Seborrheic Blepharitis

Keywords

seborrheic blepharitistea tree oilbaby shampooswabschamomile oil

Outcome Measures

Primary Outcomes (3)

  • 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)

    Change from Baseline at 4 weeks

  • 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)

    Change from Baseline at 8 weeks

  • 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)

    Change from Baseline at 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's 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

  • +1 more secondary outcomes

Study Arms (2)

Swabs containing tea tree oil and chamomile oil

EXPERIMENTAL

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

Drug: Swabs containing tea tree oil and chamomile oil

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

Swabs containing tea tree oil and chamomile oilDRUG

Swabs will be used in 26 patients for 8 weeks and will be discontinued in the following 4 weeks.

Swabs containing tea tree oil and chamomile oil
Baby shampooDRUG

Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.

Baby shampoo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Chamomile extract

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

December 17, 2020

First Posted

December 22, 2020

Study Start

November 12, 2018

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

TU(1)