HU007 in Patients With Dry Eye Syndrome

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: HU007; Drug: Moisview Eye drop; Drug: Restasis

• Registration Number: NCT05743764
• Lead Sponsor: Huons Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-24
• Study Start: 2023-03-23
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HU007	HU007	Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Moisview	Moisview Eye drop	trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Restasis	Restasis	Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in corneal staining score	12weeks	Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline; - Oxford grading: 0(Absent) to 5(Severe)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in corneal staining score	4, 8weeks	Change in corneal staining score assessed on Oxford grading at 4, 8 weeks compared to baseline
Change from baseline in conjuctival staining score	4, 8, 12weeks	Change in conjuctival staining score assessed on Oxford grading at 4, 8, 12 weeks compared to baseline
Change from baseline in strip meniscometry score	4, 8, 12weeks	Change in strip meniscometry score at 4, 8, 12 weeks compared to baseline
Change from baseline in TBUT score	4, 8, 12weeks	Change in TBUT score at 4, 8, 12 weeks compared to baseline
Change from baseline in SPEED dry eye questionnaire score	4, 8, 12weeks	Change in SPEED dry eye questionnaire score at 4, 8, 12 weeks compared to baseline
Time to achieve 100% clearance in corneal staining	12weeks	Time to achieve 100% clearance in corneal staining up to 12 weeks

Trial Locations

Locations (1)

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of