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

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 Syndrome
• Intervention / Treatment: Drug: HU007; Drug: Restasis; Drug: Moisview

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 19
• Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
• Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

• The patients with systemic or ocular disorders affected the test result
• Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
• Being treated with systemic steroid
• Wearing contact lenses within 72 hr of screening visit
• Pregnancy or Breastfeeding

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; trehalose 3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from Baseline in Corneal staining(Oxford grading) score	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
change from Baseline in Corneal staining(Oxford grading) score	Week 4,8
change from Baseline of Conjunctival staining(Oxford grading) score	Week 4,8,12
change from Baseline of Strip meniscometry assessment	Week 4,8,12
change from Baseline of Tear film break-up time	Week 4,8,12
change from Baseline of Standard patient evaluation of eye dryness questionnaire	Week 4,8,12
arrival time of 100% clearence in Corneal staining test	Week 0-12
The number of total rescue drug usage	Week 0-12

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.
• Investigators: Study Director: Namsick Kim, Huons Co., Ltd.; Principal Investigator: Choun-Ki Joo, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: HU-007_P3

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