HU007 in Patients with Dry Eye Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: HU007; Drug: Restasis; Drug: Moisview Eye drop

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jinju, Korea, Republic of, 52727
    • Gyeongsang National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
• Best corrected visual acuity of 0.2 or higher in both eyes
• Those who voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

• 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 prior to screening visit or during clinical trial
• Pregnancy or Breastfeeding
• Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
• Patient with autoimmune disease (e.g. sjogren's syndrome)
• Patients with a history of corneal transplant or neurotrophic keratitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HU007; Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks	Drug: HU007; cyclosporine 0.02%, trehalose 3%
Active Comparator: Restasis; Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks	Drug: Restasis; cyclosporine 0.05%
Active Comparator: Moisview; trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks	Drug: Moisview Eye drop; trehalose 3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal staining score	Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline - Oxford grading: 0(Absent) to 5(Severe)	12weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.
• Investigators: Principal Investigator: Jun young Hyun, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: HUC2-007_P3-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No