Clinical trial NCT01647217: Demodex Blepharitis Treatment Study
Official title: Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Blepharitis
Keywords: Blepharitis
Demodex
Mites
Tea Tree oil
Terpinen
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Eye Institute (NEI)
First posted: 2012-07-23
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the Number of Demodex Mites
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ocular Surface Center
state: Florida
Study officials:
affiliation: BioTissue Holdings, Inc
name: Scheffer CG Tseng, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.