Influence of Obuvacaine Hydrochloride Eye Drops on the Co... | NCT04569422

Studies
Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients

NCT04569422

Sponsor

Aier School of Ophthalmology, Central South University

Status

Unknown status

Last Update Posted

Sep 29, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Meibomian Gland Massage is Important to Delay the Development of Meibomian Gland Dysfunction

Interventions

Benoxyl

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

Sep 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, 2020Actual

Primary Completion Date

Mar 21, 2021Estimated

Completion Date

May 21, 2021Estimated

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Sep 24, 2020

First Posted Date

Sep 29, 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

Sep 24, 2020

Last Update Posted Date

Sep 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JJiang Junyi, Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients, Aier School of Ophthalmology, Central South UniversityPrincipal Investigator

Lead Sponsor

Aier School of Ophthalmology, Central South UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. Therefore, we needed to collect patients' pain grades during meibomian gland massage

Detailed Description

Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.

Methods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scaleMethods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scale Group: Divided into ephedrine drop group and artificial tear drop group Research tool: Pain rating scale

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
ephedrine drop			Drug: Benoxyl

Name	Type	Description	Arm Group Labels	Other Names
Benoxyl	Drug	reduce pain	ephedrine drop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Undifferrentiated	There was no difference in the effect of obuvacaine hydrochloride on the comfort of meibomian gland massage patients	2020.01-2020.09

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy people with no chronic disease

Exclusion Criteria:

People with chronic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Meibomian gland dysfunction people with no chronic disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanyuan Yin, bachelor	Contact	18621755180		815969138@qq.com

Overall Officials

Name	Affiliation	Role
Yuanyuan Yin, bachelor	Shanghai Aier Eye Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aier School of Ophthalmology, Central South University	Recruiting	Changsha	Hunan		China

Intervention Browse Module

MeSH Terms

ID	Term
D001585	Benzoyl Peroxide

Ancestor Terms

ID	Term
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

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