Clinical trial NCT04678531: TTO Swabs Versus Baby Shampoo in Patients With Seborrehic Blepharitis
Official title: Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seborrheic Blepharitis
Keywords: seborrheic blepharitis
tea tree oil
baby shampoo
swabs
chamomile oil
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2020-12-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 using block randomization to lid wipes containing tea tree oil (TTO) and chamomile oil or baby shampoo (twice daily).

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

Primary outcomes:
measure: Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
timeFrame: Change from Baseline at 4 weeks
measure: Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
timeFrame: Change from Baseline at 8 weeks
measure: Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
measure: Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the Schirmer's test results
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the tear breakup time
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the ocular surface disease index score
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the non-invasive tear breakup time
timeFrame: 0-4-8-12 weeks
measure: Efficacy of the treatment assessed by the change in the meibomian gland loss
timeFrame: 0-4-8-12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: