Observational Study on the Improvement of Dry Eye Syndrom... | NCT06172530

Studies
Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops

NCT06172530

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Dry Eye Syndrome

Interventions

Not provided

Countries

South Korea

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

Nov 2023

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

Feb 8, 2023Actual

Primary Completion Date

May 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Dec 7, 2023

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 15, 2023Actual

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

Dec 7, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is to verify the efficacy and safety in the treatment of dry eye syndrome in patients prescribed with Diquasol eye drops as a monotherapy, or in combination with Hyaluron eye drops, or in combination with Hyaluronmax eye drops.

Detailed Description

This study is to observe the prescription patterns in routine clinical practice and assess the changes in dry eye symptoms, treatment satisfaction, and intraocular tolerance over a 12-week period in patients prescribed with Diquasol eye drops as a monotherapy or in combination with Hyaluron eye drops or Hyaluronmax eye drops for the treatment of dry eye syndrome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Assessment Variables	Changes in Tear Break-Up Time (TBUT) after 12 weeks according to each group, including monotherapy with Diquasol eye drops, combination therapy with Diquasol eye drops and Hyaluron eye drops, and combination therapy with Diquasol eye drops and Hyaluronmax eye drops.	after 12 weeks of prescription for Diquasol eye drops and Hyaluron/Hyaluronmax eye drops compared to baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 19 years and older
Patients with dry eye syndrome with TBUT of 10 or less
Individuals scheduled to receive either Diquasol eye drops as a monotherapy or a combination therapy of Diquasol eye drops with Hyaluron eye drops or Diquasol eye drops with Hyaluronmax eye drops, based on clinical judgment for the treatment of dry eye syndrome
Individuals who have voluntarily provided written consent for participation in this study

Exclusion Criteria:

Pregnant or lactating women
Individuals contraindicated according to the approval conditions of Diquasol eye drops, Hyaluron eye drops, and Hyaluronmax eye drops
Cases where the principal investigator or study personnel deem the individual unsuitable for participation in this clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Dry eye syndrom patients aged 19 years or older

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sol Jo	Contact	+82-2-3489-6299		ssoljo@hanlim.com

Overall Officials

Name	Affiliation	Role
ChounKi Joo	CK st. Mary's Eye Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CK St. Mary's Eye Clinic	Recruiting	Seoul		06531	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided