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Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01073150
Study type Interventional
Source Federal University of São Paulo
Contact
Status Completed
Phase Phase 2
Start date April 2009
Completion date November 2009

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