Dry Eye Syndromes
Conditions
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
Interventions
DRUGHU007
Cyclosporine 0.02% with Trehalose 3%
DRUGRestasis eye drop
Cyclosporine 0.05%
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal staining score-Oxford grading | Week 12 | Change from baseline in corneal staining score-Oxford grading at Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in conjunctival staining score-Oxford grading | Week 4, 8, 12 | Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12 |
| Change from baseline in strip meniscometry | Week 4, 8, 12 | Change from baseline in strip meniscometry at Week 4, 8, 12 |
| Change from baseline in corneal staining score-Oxford grading | Week 4, 8 | Change from baseline in corneal staining score-Oxford grading at Week 4, 8 |
| Change from Baseline of Standard patient evaluation of eye dryness questionnaire | at Week 4, 8, 12 | Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12 |
| Time to achieve 100% clearance on the corneal staining score | upto week 12 | Time to achieve 100% clearance on the corneal staining score |
| Change from baseline in Tear film break-up time | at Week 4, 8, 12 | Change from baseline in Tear film break-up time at Week 4, 8, 12 |
Countries
South Korea
Outcome results
None listed