Chronic BlepharitisPhase 1DBTSNCT01647217

Demodex Blepharitis Treatment Study

A Phase 1 study testing Terpinen-4-ol in people with Chronic Blepharitis, run by BioTissue Holdings, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 15 to 80 years
Conditions the study is for: Chronic Blepharitis
What is being tested?: Terpinen-4-ol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Jul 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ocular Surface Center
Miami, Florida, 33173

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Blepharitis
Being tested: Terpinen-4-ol, Placebo
Keywords: Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen
Medical subject headings: Blepharitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Terpinen-4-olDrug
Also called T4O
Lid scrub once or twice per day for one month.
PlaceboOther
Lid scrub once or twice per day for one month

Study groups in NCT01647217
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 6 weeks

Secondary outcomes (1)

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).
Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jul 2015

First posted23 Jul 2012 (estimated)
Study startFeb 2014
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Chronic BlepharitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01647217
Sponsor's protocol ID: P012-01
Other IDs: 2R44EY019586-02
Acronym: DBTS
Status last verified: May 2017
First submitted: 12 Jul 2012
Last updated: 26 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 16123406
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.
PubMed 16234455
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.
PubMed 17251800
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.
PubMed 17376393
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.
PubMed 17592319
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.
PubMed 20079929
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.
PubMed 20847679
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.
PubMed 20689407
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.
PubMed 21955627

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT01647217
Acronym / sponsor ID: DBTS / P012-01
Conditions: Chronic Blepharitis
Keywords: Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: BioTissue Holdings, IncIndustry (pharma, biotech, devices)
Collaborators: National Eye Institute (NEI)
Study start: Feb 2014
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 23 Jul 2012 (estimated)
Results: Posted 26 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Terpinen-4-ol Treatment Arm	Experimental	Drug: Terpinen-4-ol8 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.
Placepo Pads Contol Arm	Placebo comparator	Other: Placebo9 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.

Who may qualify

Ages: 15 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Terpinen-4-olAlso: T4OLid scrub once or twice per day for one month.	Drug	Terpinen-4-ol Treatment Arm
PlaceboLid scrub once or twice per day for one month	Other	Placepo Pads Contol Arm

Primary outcome

Change in the Number of Demodex Mites
Time frame: 6 weeks
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".

1 secondary outcome

Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia
Time frame: Baseline and 6 weeks

Results and safety

Results posted to the registry on 26 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Terpinen-4-ol Treatment Arm	8	7
Placepo Pads Contol Arm	9	8

Primary outcome: Change in the Number of Demodex Mites

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Mites

Measure	Terpinen-4-ol Treatment Arm n = 7	Placepo Pads Contol Arm n = 8
Value	-3 (3.1)	-0.4 (3.6)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Terpinen-4-ol Treatment Arm	0 of 8 (0%)	0 of 8 (0%)	Not reported
Placepo Pads Contol Arm	0 of 9 (0%)	0 of 9 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16123406Gao 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.
Background: PubMed 16234455Gao 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.
Background: PubMed 17251800Gao 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.
Background: PubMed 17376393Kheirkhah 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.
Background: PubMed 17592319Kheirkhah 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.
Background: PubMed 20079929Li 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.
Background: PubMed 20847679Liang 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.
Background: PubMed 20689407Liu 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.
Background: PubMed 21955627Gao 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scheffer CG Tseng, MD, PhD study chair

BioTissue Holdings, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Terpinen-4-ol in people with Chronic Blepharitis, run by BioTissue Holdings, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Number of Demodex Mites (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01647217, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.