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NCT06172530 Clinical Trial

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

Dry Eye Syndrome Clinical Trial

Official title:
Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops and Hyaluron/Hyaluronmax Eye Drops in Patients Over 19 Years Old With Dry Eye Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06172530
Other study ID # HL-DQAS-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2023
Est. completion date December 2024

Study information
Verified date November 2023
Source Hanlim Pharm. Co., Ltd.
Contact Sol Jo
Phone +82-2-3489-6299
Email ssoljo@hanlim.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of CK St. Mary's Eye Clinic Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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