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

Recruiting

• Conditions: Dry Eye Syndrome

• Registration Number: NCT06172530
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Study Timeline

• Study Start: 2023-02-08
• Status Verified: 2023-11
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Assessment Variables	after 12 weeks of prescription for Diquasol eye drops and Hyaluron/Hyaluronmax eye drops compared to baseline	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.

Trial Locations

Locations (1)

CK St. Mary's Eye Clinic; 🇰🇷 Seoul, Korea, Republic of