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Clinical Trials/NCT06172530
NCT06172530
Recruiting
Not Applicable

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

Hanlim Pharm. Co., Ltd.1 site in 1 country2,000 target enrollmentFebruary 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dry Eye Syndrome
Sponsor
Hanlim Pharm. Co., Ltd.
Enrollment
2000
Locations
1
Primary Endpoint
Primary Assessment Variables
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2023
End Date
December 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Primary Assessment Variables

Time Frame: 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.

Study Sites (1)

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