Demodex Blepharitis Treatment Study (DBTS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01647217 |
Recruitment Status :
Completed
First Posted : July 23, 2012
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Chronic Blepharitis | Drug: Terpinen-4-ol Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | July 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Terpinen-4-ol
Lid scrub once or twice per day for one month.
Other Name: T4O |
Placebo Comparator: 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.
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Other: Placebo
Lid scrub once or twice per day for one month |
- 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".
- Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia [ Time Frame: Baseline and 6 weeks ]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).
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Ages Eligible for Study: | 15 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647217
United States, Florida | |
Ocular Surface Center | |
Miami, Florida, United States, 33173 |
Study Chair: | Scheffer CG Tseng, MD, PhD | Tissue Tech Inc. |
Responsible Party: | Tissue Tech Inc. |
ClinicalTrials.gov Identifier: | NCT01647217 |
Other Study ID Numbers: |
P012-01 2R44EY019586-02 ( U.S. NIH Grant/Contract ) |
First Posted: | July 23, 2012 Key Record Dates |
Results First Posted: | July 26, 2017 |
Last Update Posted: | July 26, 2017 |
Last Verified: | May 2017 |
Blepharitis Demodex Mites Tea Tree oil Terpinen |
Blepharitis Eyelid Diseases Eye Diseases |