Chronic Blepharitis
Conditions
Keywords
Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen
Brief 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).
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.
Interventions
DRUGTerpinen-4-ol
Lid scrub once or twice per day for one month.
OTHERPlacebo
Lid scrub once or twice per day for one month
Sponsors
National Eye Institute (NEI)
BioTissue Holdings, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Demodex Mites | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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 | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm | Total |
|---|---|---|---|
| Age, Continuous | 48.6 Years STANDARD_DEVIATION 21.2 | 49 Years STANDARD_DEVIATION 18.5 | 48.8 Years STANDARD_DEVIATION 19.1 |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Terpinen-4-ol Treatment Arm | Change in the Number of Demodex Mites | -3 Mites | Standard Deviation 3.1 |
| Placepo Pads Contol Arm | Change in the Number of Demodex Mites | -0.4 Mites | Standard Deviation 3.6 |
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).
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Terpinen-4-ol Treatment Arm | Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia | -2.3 units on a scale | Standard Deviation 1.4 |
| Placepo Pads Contol Arm | Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia | -3.1 units on a scale | Standard Deviation 1.9 |