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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nahin Geha, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01073150     History of Changes
Other Study ID Numbers: Nahin Geha
Study First Received: February 19, 2010
Last Updated: February 19, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on November 24, 2014