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
Overview
- Phase
- Phase 2
- Intervention
- KSR-001-04
- Conditions
- Dry Eye Syndromes
- Sponsor
- Kukje Pharma
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and Female who over 19 years old
- •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
- •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)
- •both eyes, the corrected visual acuity is 0.2 or more
- •Written consent voluntarily to participate in this clinical trial
Exclusion Criteria
- •During this clinical trial period, When Rebamipide treatment is expected due to gastrointestinal disorder or gastritis
- •Within 90 days of the screening visit, if systemic steroid steroids or systemic immunosuppressants were used
- •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
- •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
- •Within 90 days of the screening visit, Those who have undergone vision correction surgery such as LASIK or LASIK
- •Those with intraocular pressure (IOP) exceeding 21 mmHg or with glaucoma undergoing drug treatment
- •Those with hypersensitivity to the ingredient of this clinical trial drug
- •Patients planning to wear contact lenses during the clinical trial period
- •In the case of one of the following
- •Creatinine level more than twice the upper limit of normal range
Arms & Interventions
KSR-001-04
KSR-001-04 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Intervention: KSR-001-04
KSR-001-02
KSR-001-02 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Intervention: KSR-001-02
KSR-001-03
KSR-001-03 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Intervention: KSR-001-03
Outcomes
Primary Outcomes
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time Frame: Baseline, 12 weeks
FCS indicates the damage to the corneal epithelium. The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source was evaluated according to the National Eye Institute/Industry grading system. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15)(0 is better).
Secondary Outcomes
- Fluorescein Corneal Staining (FCS)(Baseline, 4 weeks, 8 weeks)
- Lissamine Green Conjunctival Staining (LGCS)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Ocular Surface Disease Index (OSDI)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Unanesthetized Schirmer's test(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Tear Film Break-up Time (TBUT)(Baseline, 4 weeks, 8 weeks, 12 weeks)