Treatment of Ocular Demodicosis by Cleansing the Eyelid M... | NCT04451122

Studies
Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment

NCT04451122

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jun 30, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Mite-Borne

Interventions

cleansing the eyelid margins

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Jun 26, 2020

First Posted Date

Jun 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2020

Last Update Posted Date

Jun 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

yin ying zhao, Researcher；clinical research center, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 tree oil eyelid margin + eyelid cleansing, and participants were rechecked after 3 months of regular medication.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment of ocular demodicosis	Other		Other: cleansing the eyelid margins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cleansing the eyelid margins	Other	using eyelid cleaning wipes to cleansing the eyelid margins	Treatment of ocular demodicosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The severity of dry eyes	OSDI dry eye questionnaire	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosisof ocular surface mite parasitism

Exclusion Criteria:

any acute keratoconjunctivitis;c dacryocystitis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Wenzhou Medical College	Recruiting	Wenzhou	Zhejiang	325027	China

Intervention Browse Module

MeSH Terms

ID	Term
D020947	Tea Tree Oil

Ancestor Terms

ID	Term
D009822	Oils, Volatile
D009821	Oils
D008055	Lipids
D010938	Plant Oils
D028321

Browse Leaves

Not provided

Browse Branches

Not provided