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Tea Tree Oil in the Treatment of Chronic Blepharitis

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01073150
First received: February 19, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 19, 2010
February 19, 2010
April 2009
August 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Tea Tree Oil in the Treatment of Chronic Blepharitis
Tea Tree Oil in the Treatment of Chronic Blepharitis

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Blepharitis
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
November 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01073150
Nahin Geha
Yes
Nahin Geha, Federal University of Sao Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Nahin Geha Federal University of São Paulo
Federal University of São Paulo
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP