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Tea Tree Oil in the Treatment of Chronic Blepharitis

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Tea Tree Oil
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Tea Tree Oil, Chronic Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Federal University of Sao Paulo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 19, 2010
Last Updated
February 19, 2010
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01073150
Brief Title
Tea Tree Oil in the Treatment of Chronic Blepharitis
Official Title
Tea Tree Oil in the Treatment of Chronic Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
Keywords
Tea Tree Oil, Chronic Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tea Tree Oil
Intervention Description
Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week for six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahin Geha
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038040
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Tea Tree Oil in the Treatment of Chronic Blepharitis

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