Demodex Blepharitis Treatment Study (DBTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Tissue Tech Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tissue Tech Inc.
ClinicalTrials.gov Identifier:
NCT01647217
First received: July 12, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Chronic Blepharitis
Drug: Terpinen-4-ol
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial

Further study details as provided by Tissue Tech Inc.:

Primary Outcome Measures:
  • Eradication of Demodex Mites [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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".


Secondary Outcome Measures:
  • Change in Lid Margin redness and Bulbar Conjunctival Hyperemia [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terpinen-4-ol Treatment Arm
30 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (15 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.
Drug: Terpinen-4-ol
Lid scrub once or twice per day for one month.
Other Name: T4O
Placebo Comparator: Placepo Pads Contol Arm
30 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (15 each) 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
Lid scrub once or twice per day for one month

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

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647217

Contacts
Contact: Hosam El Sheha, MD, PhD 305-274-1299 hoss88@gmail.com

Locations
United States, Florida
Ocular Surface Center Recruiting
Miami, Florida, United States, 33173
Contact: Hosam El Sheha, MD, PhD         
Principal Investigator: Scheffer CG Tseng, MD, PhD         
Sub-Investigator: Hosam El Sheha, MD, PhD         
Sponsors and Collaborators
Tissue Tech Inc.
Investigators
Study Chair: Scheffer CG Tseng, MD, PhD Tissue Tech Inc.
  More Information

Publications:

Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT01647217     History of Changes
Other Study ID Numbers: P012-01, 2R44EY019586-02
Study First Received: July 12, 2012
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tissue Tech Inc.:
Blepharitis
Demodex
Mites
Tea Tree oil
Terpinen

Additional relevant MeSH terms:
Blepharitis
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on October 29, 2014