HU007 Eye Drops in Patients With Dry Eye Syndrome

NCT ID: NCT04384991

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-03
• Study Completion Date: 2019-12-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

HU007

Intervention Type: DRUG

Cyclosporine 0.02% with Trehalose 3%

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)

Group Type: ACTIVE_COMPARATOR

Restasis eye drop

Intervention Type: DRUG

Cyclosporine 0.05%

Interventions

HU007

Cyclosporine 0.02% with Trehalose 3%

Intervention Type: DRUG

Restasis eye drop

Cyclosporine 0.05%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huons Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Countries

South Korea

Other Identifiers

HU-007_P3-1

Identifier Type: -

Identifier Source: org_study_id