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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Sol Jo; Phone Number: +82-2-3489-6299; Email: ssoljo@hanlim.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06531
    • Recruiting
    • CK St. Mary's Eye Clinic
    • Contact: ChounKi Joo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Dry eye syndrom patients aged 19 years or older

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: ChounKi Joo, CK St. Mary's Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: HL-DQAS-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No