Tea Tree Oil in the Treatment of Chronic Blepharitis

NCT ID: NCT01073150

Last Updated: 2010-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Sao Paulo

Principal Investigators

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Nahin Geha

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Nahin Geha

Identifier Type: -

Identifier Source: org_study_id

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