Status:
COMPLETED
HU007 Eye Drops in Patients With Dry Eye Syndrome
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04384991
Start Date
May 3 2019
End Date
December 5 2019
Last Update
May 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam, South Korea