Tea Tree Oil in the Treatment of Chronic Blepharitis

Blepharitis Clinical Trial

Official title:

Tea Tree Oil in the Treatment of Chronic Blepharitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073150
• Other study ID #: Nahin Geha
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2010
• Last updated: February 19, 2010
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine:

• The prevalence of Demodex sp. in chronic blepharitis.

• The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex sp.

Description:

Patients with clinical diagnosis of chronic blepharitis were included in this study. A check list of symptoms and an ophthalmologic examination including best corrected visual acuity and biomicroscopy were performed.

Under a slit lamp visualization, three lashes with cylindrical dandruff of each eyelid were epilated by fine forceps. The lashes were immersed in fluorescein dye and examined under a light microscope at a 20-times magnification. The mites were detected based on its morphological characteristics and movement.

The patients with chronic blepharitis who had Demodex were randomly divided in two groups. The treatment group was prescribed lid hygiene with Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week - produced by Ophthalmos, São Paulo. The control group used the same posology of placebo similar products.

After six weeks, all subjects underwent the initial clinical and laboratory examination. The symptoms and the quantity of mites (mites/eye) were compared before and after the treatment in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Blepharitis with out treatment previously

Exclusion Criteria:

• Patients under 18 y.o.

• Pregnant woman

• Others Ocular Surface Disease (Severe Dry Eye, Lagoftalmo, Entropium, Ectropium)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Tea Tree Oil
Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week for six weeks

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil,