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
About this trial
This is an interventional treatment trial for Blepharitis focused on measuring Tea Tree Oil, Chronic Blepharitis
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)
Sites / Locations
- Federal University of Sao Paulo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01073150
First Posted
February 19, 2010
Last Updated
February 19, 2010
Sponsor
Federal University of São Paulo
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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