Mite-BorneNCT04451122
Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment
A study testing cleansing the eyelid margins in people with Mite-Borne, run by Wenzhou Medical University at 1 site in China.
Trial summary
To investigate whether the cleaning of eyelid margins increases the effectiveness of traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided 60 participants into two groups: Group A was treated with traditional tea tree oil eyelid margin, Group B was treated with traditional tea… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mite-Borne
- What is being tested?
- cleansing the eyelid margins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosisof ocular surface mite parasitism
Who cannot join
- any acute keratoconjunctivitis;c dacryocystitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Dandan Wang, MD, 18258227706, wangdan4827716@yahoo.com.cn
About this study
To investigate whether the cleaning of eyelid margins increases the effectiveness of traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided 60 participants into two groups: Group A was treated with traditional tea tree oil eyelid margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing, and participants were rechecked after 3 months of regular medication.
- Conditions
- Mite-Borne
- Being tested
- cleansing the eyelid margins
- Keywords
- eyelid margins, ocular demodicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleansing the eyelid marginsOther
Also called tea tree oil
using eyelid cleaning wipes to cleansing the eyelid margins
| Study group | Role | What they receive |
|---|---|---|
| Treatment of ocular demodicosis | Other | Not described Receives: Other: cleansing the eyelid margins |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of dry eyes
OSDI dry eye questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jun 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mite-BorneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451122
- Sponsor's protocol ID
- demodicosis WDD
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment
- ClinicalTrials.gov ID
- NCT04451122
- Acronym / sponsor ID
- demodicosis WDD
- Conditions
- Mite-Borne
- Keywords
- eyelid margins, ocular demodicosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether the cleaning of eyelid margins increases the effectiveness of traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided 60 participants into two groups: Group A was treated with traditional tea tree oil eyelid margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing, and participants were rechecked after 3 months of regular medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of ocular demodicosis | Other | Other: cleansing the eyelid margins |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosisof ocular surface mite parasitism
Key exclusion criteria (1 listed)
- any acute keratoconjunctivitis;c dacryocystitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cleansing the eyelid marginsAlso: tea tree oilusing eyelid cleaning wipes to cleansing the eyelid margins | Other | Treatment of ocular demodicosis |
Primary outcome
The severity of dry eyes
Time frame: 3 months
OSDI dry eye questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cleansing the eyelid margins in people with Mite-Borne, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of dry eyes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.