Demodex Blepharitis Treatment Study

Chronic Blepharitis Clinical Trial

— DBTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01647217
• Other study ID #: P012-01
• Secondary ID: 2R44EY019586-02
• Status: Recruiting
• Phase: Phase 1
• First received: July 12, 2012
• Last updated: July 15, 2014
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: Tissue Tech Inc.
• Contact: Hosam El Sheha, MD, PhD
• Phone: 305-274-1299
• Email: hoss88[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Blepharitis
• Chronic Blepharitis

Intervention

Drug:
• Terpinen-4-ol
Lid scrub once or twice per day for one month.

Other:
• Placebo
Lid scrub once or twice per day for one month

Locations

Country	Name	City	State
United States	Ocular Surface Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Tissue Tech Inc.	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Mar 21. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of Demodex Mites	Reduction 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".	4 months	Yes
Secondary	Change in Lid Margin redness and Bulbar Conjunctival Hyperemia	Lid margin redness and bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). Hyperemia will be graded on the following scale and half scores are acceptable: None (0) = normal; Mild (1) = Slight localized injection; Moderate (2) = pink color; Severe (3) = dark redness	Baseline and 4 months	No