A Phase 1 interventional study of Terpinen-4-ol and Placebo in Chronic Blepharitis, sponsored by BioTissue Holdings, Inc. Completed at 1 site in United States. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by BioTissue Holdings, Inc · Phase 1, Interventional, and Treatment
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.
70 studies on the registry are indexed under Blepharitis; 5 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 62 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →BioTissue Holdings, Inc is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Terpinen-4-ol
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.
Other: Placebo
Lid scrub once or twice per day for one month.
Also known as: T4O
Lid scrub once or twice per day for one month
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
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
| Milestone | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm |
|---|---|---|
| Started | 8 | 9 |
| Completed | 7 | 8 |
| Not completed | 1 | 1 |
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".
| Mites | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm |
|---|---|---|
| Change in the Number of Demodex Mites | -3 ± 3.1 | -0.4 ± 3.6 |
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).
| units on a scale | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm |
|---|---|---|
| Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia | -2.3 ± 1.4 | -3.1 ± 1.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Terpinen-4-ol Treatment Arm | — | 0/8 (0%) | 0/8 (0%) |
| Placepo Pads Contol Arm | — | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(Years) | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm | Total |
|---|---|---|---|
| Mean | 48.6 ± 21.2 | 49 ± 18.5 | 48.8 ± 19.1 |
| Sex: Female, Male(Participants) | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 4 | 3 | 7 |
| Region of Enrollment(participants) | Terpinen-4-ol Treatment Arm | Placepo Pads Contol Arm | Total |
|---|---|---|---|
| United States | 8 | 9 | 17 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BioTissue Holdings, Inc