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NCT05743764 Clinical Trial

HU007 in Patients With Dry Eye Syndrome

Dry Eye Disease Clinical Trial

Official title:
A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05743764
Other study ID # HUC2-007_P3-2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 23, 2023
Est. completion date February 14, 2024

Study information
Verified date February 2023
Source Huons Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

Recruitment information / eligibility
Status Completed
Enrollment 328
Est. completion date February 14, 2024
Est. primary completion date February 14, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria - Age over 19 - Corneal staining score(Oxford grading) = 2 and Schirmer test = 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test = 3mm/5min) and TBUT test =10 in at least one of both eyes - Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit. Exclusion Criteria: - The patients with clinically significant ocular disorders affected the test result - Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status - SBP =140mmHg or DBP = 90mmHg or HbA1c>9% - Wearing contact lenses within 72 hr of screening visit - Pregnancy or Breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HU007
cyclosporine 0.02%, trehalose 3%
• Restasis
cyclosporine 0.05%
• Moisview Eye drop
trehalose 3%

Locations
Country Name City State
Korea, Republic of Gyeongsang National University Hospital Jinju

Sponsors (1)
Lead Sponsor Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from Baseline in Corneal staining(Oxford grading) score change from Baseline in Corneal staining(Oxford grading) score
- Oxford grading:0(Absent) to 5(Severe)		 Week12
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