HU007 Eye Drops in Patients With Dry Eye Syndrome

A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, 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 Syndromes
• Intervention / Treatment: Drug: HU007; Drug: Restasis eye drop

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male and Female who over 19 years old

• Those who meet below criteria at least one of two eyes

  1. Those who have over than score 2 in corneal staining test-Oxford grading
  2. Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
  3. TBUT(Tear film break-up time) test result should be under 10sec.
• Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
• Those who could understand this study and agree to informed consent voluntarily

Exclusion Criteria:

• Those who have clinically significant eye disease not related to dry eye symdrome
• Those who are in anti-inflammatory medication for dry eye syndrome
• Medication of systemic steroid or immunosuppressant
• Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
• Those who have medical history with intraocular surgery 90 days before screening visit
• Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
• Those who have any autoimmune diseases
• Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
• Those who have any medical history of corneal transplantation or neurotrophic keratitis
• Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
• Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
• Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
• Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
• Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
• Those who have diagnosed a psychical disorder which could affect this study
• Women who is pregnant or breastfeeding or those who have a plan to be pregnant
• Those who have medical history on abusing medications or alchol
• Those who have received other investigational drugs/devices 30 days before screening visit
• Those who are inappropriate for participating in this study according to investigator's judgement

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HU007 Eye drop; Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)	Drug: HU007; Cyclosporine 0.02% with Trehalose 3%
Active Comparator: Restasis Eye drop 0.05% (Cyclosporine); Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)	Drug: Restasis eye drop; Cyclosporine 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal staining score-Oxford grading	Change from baseline in corneal staining score-Oxford grading at Week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal staining score-Oxford grading	Change from baseline in corneal staining score-Oxford grading at Week 4, 8	Week 4, 8
Change from baseline in conjunctival staining score-Oxford grading	Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12	Week 4, 8, 12
Change from baseline in strip meniscometry	Change from baseline in strip meniscometry at Week 4, 8, 12	Week 4, 8, 12
Change from baseline in Tear film break-up time	Change from baseline in Tear film break-up time at Week 4, 8, 12	at Week 4, 8, 12
Change from Baseline of Standard patient evaluation of eye dryness questionnaire	Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12	at Week 4, 8, 12
Time to achieve 100% clearance on the corneal staining score	Time to achieve 100% clearance on the corneal staining score	upto week 12

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

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; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: HU-007_P3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD would be substituted for screening or random 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