HU007 Eye Drops in Patients With Dry Eye Syndrome

Launched by HUONS CO., LTD. · May 11, 2020

Keywords

ClinConnect Summary

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Gender

ALL

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