NCT01647217

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2014

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

First Submitted

Initial submission to the registry

July 12, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 26, 2017

Completed
Last Updated

July 26, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

July 12, 2012

Results QC Date

November 5, 2015

Last Update Submit

May 31, 2017

Conditions

Chronic Blepharitis

Keywords

BlepharitisDemodexMitesTea Tree oilTerpinen

Outcome Measures

Primary Outcomes (1)

  • 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".

    6 weeks

Secondary Outcomes (1)

  • Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia

    Baseline and 6 weeks

Study Arms (2)

Terpinen-4-ol Treatment Arm

EXPERIMENTAL

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.

Drug: Terpinen-4-ol

Placepo Pads Contol Arm

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Terpinen-4-olDRUG

Lid scrub once or twice per day for one month.

Also known as: T4O
Terpinen-4-ol Treatment Arm
PlaceboOTHER

Lid scrub once or twice per day for one month

Placepo Pads Contol Arm

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ocular Surface Center

Miami, Florida, 33173, United States

Location

Related Publications (9)

  • 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.

    PMID: 16123406BACKGROUND

  • 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.

    PMID: 16234455BACKGROUND

  • 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.

    PMID: 17251800BACKGROUND

  • 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.

    PMID: 17376393BACKGROUND

  • 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.

    PMID: 17592319BACKGROUND

  • 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.

    PMID: 20079929BACKGROUND

  • 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.

    PMID: 20847679BACKGROUND

  • 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.

    PMID: 20689407BACKGROUND

  • 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.

    PMID: 21955627BACKGROUND

MeSH Terms

Conditions

Blepharitis

Interventions

terpinenol-4

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Results Point of Contact

Title
Hosam El Sheha, MD, PhD
Organization
Tissuetech Inc
hsheha@tissuetechinc.com
305-274-1299

Study Officials

  • Scheffer CG Tseng, MD, PhD

    BioTissue Holdings, Inc

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 23, 2012

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 26, 2017

Results First Posted

July 26, 2017

Record last verified: 2017-05

Locations

US(1)