Clinical trial NCT04384991: HU007 Eye Drops in Patients With Dry Eye Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 216
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change from baseline in corneal staining score-Oxford grading
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline in corneal staining score-Oxford grading
timeFrame: Week 4, 8
measure: Change from baseline in conjunctival staining score-Oxford grading
timeFrame: Week 4, 8, 12
measure: Change from baseline in strip meniscometry
timeFrame: Week 4, 8, 12
measure: Change from baseline in Tear film break-up time
timeFrame: at Week 4, 8, 12
measure: Change from Baseline of Standard patient evaluation of eye dryness questionnaire
timeFrame: at Week 4, 8, 12
measure: Time to achieve 100% clearance on the corneal staining score
timeFrame: upto week 12
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: