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NCT01647217 · ClinicalTrials.gov registry record · Phase 1
Demodex Blepharitis Treatment Study
A Phase 1 study, sponsored by BioTissue Holdings.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01647217: Completed Phase 1 study, sponsored by BioTissue Holdings.
NCT01647217 is a Phase 1 study that has completed, run by BioTissue Holdings. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647217, a Phase 1 study, has completed, sponsored by BioTissue Holdings.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study 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).
Primary Outcome
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".
Interventions
- OTHER Placebo
- DRUG Terpinen-4-ol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01647217 record still lists
NCT01647217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01647217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01647217 about?
NCT01647217 is a clinical study titled "Demodex Blepharitis Treatment Study". 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).
What is the current status of trial NCT01647217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01647217?
The interventions under investigation include: Placebo (OTHER), Terpinen-4-ol (DRUG).
Who is sponsoring clinical trial NCT01647217?
This trial is sponsored by BioTissue Holdings, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01647217's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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