Overview

HU007 Eye Drops in Patients With Dry Eye Syndrome

Status:
Completed
Trial end date:
2019-12-05
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Huons Co., Ltd.
Treatments:
Ophthalmic Solutions
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