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Demodex Blepharitis Treatment Study (DBTS)

Primary Purpose

Chronic Blepharitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Terpinen-4-ol

Placebo

About this trial

This is an interventional treatment trial for Chronic Blepharitis focused on measuring Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ocular Surface Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Terpinen-4-ol Treatment Arm

Placepo Pads Contol Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the Number of Demodex Mites

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".

Secondary Outcome Measures

Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia

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).

Full Information

NCT ID

NCT01647217

First Posted

July 12, 2012

Last Updated

May 31, 2017

Sponsor

Tissue Tech Inc.

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT01647217

Brief Title

Demodex Blepharitis Treatment Study

Acronym

DBTS

Official Title

Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tissue Tech Inc.

Collaborators

National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Blepharitis

Keywords

Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Terpinen-4-ol Treatment Arm

Arm Type

Experimental

Arm Description

Arm Title

Placepo Pads Contol Arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Terpinen-4-ol

Other Intervention Name(s)

T4O

Intervention Description

Lid scrub once or twice per day for one month.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Lid scrub once or twice per day for one month

Primary Outcome Measure Information:

Title

Change in the Number of Demodex Mites

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia

Description

Time Frame

Baseline and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scheffer CG Tseng, MD, PhD

Organizational Affiliation

Tissue Tech Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Ocular Surface Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16123406

Citation

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.

Results Reference

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PubMed Identifier

16234455

Citation

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.

Results Reference

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PubMed Identifier

17251800

Citation

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.

Results Reference

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PubMed Identifier

17376393

Citation

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.

Results Reference

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PubMed Identifier

17592319

Citation

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.

Results Reference

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PubMed Identifier

20079929

Citation

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.

Results Reference

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PubMed Identifier

20847679

Citation

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.

Results Reference

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PubMed Identifier

20689407

Citation

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.

Results Reference

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PubMed Identifier

21955627

Citation

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.

Results Reference

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Demodex Blepharitis Treatment Study

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