NCT01073150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

February 19, 2010

Last Update Submit

February 19, 2010

Conditions

Blepharitis

Keywords

Tea Tree OilChronic Blepharitis

Interventions

Tea Tree OilDRUG

Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week for six weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Blepharitis with out treatment previously

You may not qualify if:

  • Patients under 18 y.o.
  • Pregnant woman
  • Others Ocular Surface Disease (Severe Dry Eye, Lagoftalmo, Entropium, Ectropium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04038040, Brazil

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Tea Tree Oil

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Oils, VolatileOilsLipidsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Nahin Geha

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 23, 2010

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

BR(1)