- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647217
Demodex Blepharitis Treatment Study (DBTS)
May 31, 2017 updated by: Tissue Tech Inc.
Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Demodex blepharitis is one of the most common causes of chronic blepharitis.
The investigators preliminary clinical study showed that lid scrub with TTO was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients.
Preclinical safety studies have verified that T4O is less irritant.
In this study, the investigators will determine the optimal regimen of T4O Pads.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33173
- Ocular Surface Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
- Age range: 15-80 years old.
- Both genders and all ethnic groups comparable with the local community.
- Able to understand and willing to sign a written informed consent
- Able and willing to cooperate with the investigational plan.
- Able and willing to complete all mandatory follow-up visits.
Exclusion Criteria:
- Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
- Children under 15.
- Pregnant women or expecting to be pregnant during the study.
- Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
- Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
- Concomitant use of systemic antibiotics or steroids.
- Contact lens wear (unless discontinued for ≥ 30 days before randomization)
- Active ocular infection or allergy
- Unable to close eyes or uncontrolled blinking
- Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
- Previous allergic reaction to TTO-containing products or cosmetic fragrance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Terpinen-4-ol Treatment Arm
8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day).
Changes in the mite counts will be correlated with changes in symptoms and signs.
|
Lid scrub once or twice per day for one month.
Other Names:
|
Placebo Comparator: Placepo Pads Contol Arm
9 patients will be randomized into the control group and will be treated with placebo pads.
They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day).
Changes in the mite counts will be correlated with changes in symptoms and signs.
|
Lid scrub once or twice per day for one month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Number of Demodex Mites
Time Frame: 6 weeks
|
Change in mites count after treatment compared to the baseline data.
If the mites' count remains zero during the last two visits, it is considered "complete eradication".
Patients without achieving complete eradication will be categorized as "incomplete eradication".
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia
Time Frame: Baseline and 6 weeks
|
Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe).
The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).
|
Baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Scheffer CG Tseng, MD, PhD, Tissue Tech Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gao YY, Di Pascuale MA, Li W, Liu DT, Baradaran-Rafii A, Elizondo A, Kawakita T, Raju VK, Tseng SC. High prevalence of Demodex in eyelashes with cylindrical dandruff. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3089-94. doi: 10.1167/iovs.05-0275.
- Gao YY, Di Pascuale MA, Li W, Baradaran-Rafii A, Elizondo A, Kuo CL, Raju VK, Tseng SC. In vitro and in vivo killing of ocular Demodex by tea tree oil. Br J Ophthalmol. 2005 Nov;89(11):1468-73. doi: 10.1136/bjo.2005.072363.
- Gao YY, Di Pascuale MA, Elizondo A, Tseng SC. Clinical treatment of ocular demodecosis by lid scrub with tea tree oil. Cornea. 2007 Feb;26(2):136-43. doi: 10.1097/01.ico.0000244870.62384.79.
- Kheirkhah A, Casas V, Li W, Raju VK, Tseng SC. Corneal manifestations of ocular demodex infestation. Am J Ophthalmol. 2007 May;143(5):743-749. doi: 10.1016/j.ajo.2007.01.054. Epub 2007 Mar 21.
- Kheirkhah A, Blanco G, Casas V, Tseng SC. Fluorescein dye improves microscopic evaluation and counting of demodex in blepharitis with cylindrical dandruff. Cornea. 2007 Jul;26(6):697-700. doi: 10.1097/ICO.0b013e31805b7eaf.
- Li J, O'Reilly N, Sheha H, Katz R, Raju VK, Kavanagh K, Tseng SC. Correlation between ocular Demodex infestation and serum immunoreactivity to Bacillus proteins in patients with Facial rosacea. Ophthalmology. 2010 May;117(5):870-877.e1. doi: 10.1016/j.ophtha.2009.09.057. Epub 2010 Jan 15.
- Liang L, Safran S, Gao Y, Sheha H, Raju VK, Tseng SC. Ocular demodicosis as a potential cause of pediatric blepharoconjunctivitis. Cornea. 2010 Dec;29(12):1386-91. doi: 10.1097/ICO.0b013e3181e2eac5.
- Liu J, Sheha H, Tseng SC. Pathogenic role of Demodex mites in blepharitis. Curr Opin Allergy Clin Immunol. 2010 Oct;10(5):505-10. doi: 10.1097/ACI.0b013e32833df9f4.
- Gao YY, Xu DL, Huang lJ, Wang R, Tseng SC. Treatment of ocular itching associated with ocular demodicosis by 5% tea tree oil ointment. Cornea. 2012 Jan;31(1):14-7. doi: 10.1097/ICO.0b013e31820ce56c.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (Estimate)
July 23, 2012
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
May 31, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P012-01
- 2R44EY019586-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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