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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | CK St. Mary's Eye Clinic | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
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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