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Tea Tree Oil in the Treatment of Chronic Blepharitis

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01073150
Collaborator
(none)
34
Enrollment
1
Location
7
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tea Tree Oil
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Tea Tree Oil in the Treatment of Chronic Blepharitis
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01073150
    Other Study ID Numbers:
    • Nahin Geha
    First Posted:
    Feb 23, 2010
    Last Update Posted:
    Feb 23, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Tea Tree Oil
    Chronic Blepharitis
    Additional relevant MeSH terms:
    Blepharitis
    Tea Tree Oil

    Study Results

    No Results Posted as of Feb 23, 2010