Clinical trial NCT05017844: [KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel Phase 2b/3 Study to Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Kukje Pharma
Sponsor class: OTHER
Collaborators: name: Samil Pharmaceutical Co., Ltd.
First posted: 2021-08-24
Enrollment: 222
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: The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

1. Male and Female who over 19 years old
2. Those who have had symptoms of dry eye for at least 6 months (foreign body sensation, dryness, glare, pain pain, blurred vision, etc.) and Those whose symptoms do not improve with conservative treatment such as artificial tears
3. Those who meet below criteria at least one of two eyes

   * Those who have over than score 4 in corneal staining test
   * 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)
4. both eyes, the corrected visual acuity is 0.2 or more
5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. During this clinical trial period, When Rebamipide treatment is expected due to gastrointestinal disorder or gastritis
2. Within 90 days of the screening visit, if systemic steroid steroids or systemic immunosuppressants were used
3. Within 90 days of the screening visit, If there is a history of other ophthalmic surgeries including the use of punctum plugs or puncture closure surgery
4. If it is a clinically significant ophthalmic disease that is not caused by dry eye syndrome and may affect the interpretation of the results of this clinical trial
5. Within 90 days of the screening visit, Those who have undergone vision correction surgery such as LASIK or LASIK
6. Those with intraocular pressure (IOP) exceeding 21 mmHg or with glaucoma undergoing drug treatment
7. Those with hypersensitivity to the ingredient of this clinical trial drug
8. Patients planning to wear contact lenses during the clinical trial period
9. In the case of one of the following

   * Creatinine level more than twice the upper limit of normal range
   * AST or ALT levels greater than twice the upper limit of normal range
10. History of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery)
11. Within 1 year before screening, Those who have been diagnosed with alcohol or drug abuse and are receiving treatment
12. In the case of women of childbearing potential, those who do not consent to contraception by a medically accepted method of contraception during the clinical trial period (IUD, Intrauterine device or IUS, Intrauterine system), tubal ligation, double blocking method (male condom, female condoms, cervical caps, contraceptive diaphragms, and Combination of blocking methods such as contraceptive sponges)
13. Pregnant or lactating women
14. within 30 days before participating in the clinical trial, Those who have applied other clinical trial drugs or medical devices
15. Patients judged by other investigators as unsuitable to participate in this clinical trial

Primary outcomes:
measure: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Fluorescein Corneal Staining (FCS)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Lissamine Green Conjunctival Staining (LGCS)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Unanesthetized Schirmer's test
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Tear Film Break-up Time (TBUT)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Kukje Pharma
Study officials:
References: