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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44EY019586-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terpinen-4-ol | Drug | Lid scrub once or twice per day for one month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scheffer CG Tseng, MD, PhD | BioTissue Holdings, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Surface Center | Miami | Florida | 33173 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16123406 | Background | 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. | |
| 16234455 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Terpinen-4-ol: Lid scrub once or twice per day for one month. |
| FG001 | 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. Placebo: Lid scrub once or twice per day for one month |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Terpinen-4-ol: Lid scrub once or twice per day for one month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Posted | Mean | Standard Deviation | Mites | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Terpinen-4-ol Treatment Arm | 10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Terpinen-4-ol: Lid scrub once or twice per day for one month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hosam El Sheha, MD, PhD | Tissuetech Inc | 305-274-1299 | hsheha@tissuetechinc.com |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C034019 | terpinenol-4 |
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| Placebo | Other | Lid scrub once or twice per day for one month |
|
| 17251800 | Background | 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. |
| 17376393 | Background | 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. |
| 17592319 | Background | 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. |
| 20079929 | Background | 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. |
| 20847679 | Background | 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. |
| 20689407 | Background | 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. |
| 21955627 | Background | 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. |
| BG001 |
| 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. Placebo: Lid scrub once or twice per day for one month |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
Placebo: Lid scrub once or twice per day for one month
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placepo Pads Contol Arm | 10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Placebo: Lid scrub once or twice per day for one month | 0 | 9 | 0 | 9 |
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