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Tea Tree Oil in the Treatment of Chronic Blepharitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073150
First Posted: February 23, 2010
Last Update Posted: February 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose

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.

Condition Intervention Phase
Blepharitis Drug: Tea Tree Oil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tea Tree Oil in the Treatment of Chronic Blepharitis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Enrollment: 34
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073150


Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04038040
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Nahin Geha Federal University of São Paulo
  More Information

Responsible Party: Nahin Geha, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01073150     History of Changes
Other Study ID Numbers: Nahin Geha
First Submitted: February 19, 2010
First Posted: February 23, 2010
Last Update Posted: February 23, 2010
Last Verified: February 2010

Keywords provided by Federal University of São Paulo:
Tea Tree Oil
Chronic Blepharitis

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Tea Tree Oil
Anti-Infective Agents, Local
Anti-Infective Agents