HU007 Eye Drops in Patients With Dry Eye Syndrome

NCT04384991 | Completed Phase 3

• 1 other identifier: HU-007_P3-1
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in corneal staining score-Oxford grading

  Change from baseline in corneal staining score-Oxford grading at Week 12

  Week 12

Secondary Outcomes (6)

• Change from baseline in corneal staining score-Oxford grading

  Week 4, 8

• Change from baseline in conjunctival staining score-Oxford grading

  Week 4, 8, 12

• Change from baseline in strip meniscometry

  Week 4, 8, 12

• Change from baseline in Tear film break-up time

  at Week 4, 8, 12

• Change from Baseline of Standard patient evaluation of eye dryness questionnaire

  at Week 4, 8, 12

Study Arms (2)

HU007 Eye drop

EXPERIMENTAL

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

Restasis Eye drop 0.05% (Cyclosporine)

ACTIVE COMPARATOR

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

Interventions

HU007 DRUG

Cyclosporine 0.02% with Trehalose 3%

HU007 Eye drop

Restasis eye drop DRUG

Cyclosporine 0.05%

Restasis Eye drop 0.05% (Cyclosporine)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female who over 19 years old
• Those who meet below criteria at least one of two eyes
• Those who have over than score 2 in corneal staining test-Oxford grading
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: May 12, 2020
• Study Start: May 3, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)