Back to results[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KSR-001-04
KSR-001-02
KSR-001-03
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
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
- AST or ALT levels greater than twice the upper limit of normal range
- History of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery)
- Within 1 year before screening, Those who have been diagnosed with alcohol or drug abuse and are receiving treatment
- 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)
- Pregnant or lactating women
- within 30 days before participating in the clinical trial, Those who have applied other clinical trial drugs or medical devices
- Patients judged by other investigators as unsuitable to participate in this clinical trial
Sites / Locations
- Kukje Pharma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
KSR-001-04
KSR-001-02
KSR-001-03
Arm Description
KSR-001-04 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
KSR-001-02 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
KSR-001-03 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Outcomes
Primary Outcome Measures
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
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 Outcome Measures
Fluorescein Corneal Staining (FCS)
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.
Lissamine Green Conjunctival Staining (LGCS)
After lysamine green staining under slit lamps, the conjunctival staining was evaluated according to the National Eye Institute/Industry grading system.
Unanesthetized Schirmer's test
After the eyes were wiped and the Schirmer test paper was inserted into the right eye at 1/3 of the lower eyelid without eye anesthesia and inserted into the left eye. After 5 minutes with the eyes closed, the Schirmer test paper was removed from the right side in the order of insertion and the left side removed. The wet length was measured in millimeters and the length of the midpoint was measured when the wet border was oblique.
Tear Film Break-up Time (TBUT)
After blinking blue fluorescein staining of the cobalt blue light source, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.
Ocular Surface Disease Index (OSDI)
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for none of the time, 1 point for some of the time, 2 points for half of the time, 3 points for most of the time, and 4 points for all of the time.
Full Information
NCT ID
NCT05017844
First Posted
August 19, 2021
Last Updated
August 23, 2021
Sponsor
Kukje Pharma
Collaborators
Samil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05017844
Brief Title
[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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kukje Pharma
Collaborators
Samil Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KSR-001-04
Arm Type
Placebo Comparator
Arm Description
KSR-001-04 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Arm Title
KSR-001-02
Arm Type
Experimental
Arm Description
KSR-001-02 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Arm Title
KSR-001-03
Arm Type
Experimental
Arm Description
KSR-001-03 eyedrops recieved one drop to both eyes four times a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
KSR-001-04
Intervention Description
One drop to both eyes four times a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
KSR-001-02
Intervention Description
One drop to both eyes four times a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
KSR-001-03
Intervention Description
One drop to both eyes four times a day for 12 weeks
Primary Outcome Measure Information:
Title
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Description
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).
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Fluorescein Corneal Staining (FCS)
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Lissamine Green Conjunctival Staining (LGCS)
Description
After lysamine green staining under slit lamps, the conjunctival staining was evaluated according to the National Eye Institute/Industry grading system.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Unanesthetized Schirmer's test
Description
After the eyes were wiped and the Schirmer test paper was inserted into the right eye at 1/3 of the lower eyelid without eye anesthesia and inserted into the left eye. After 5 minutes with the eyes closed, the Schirmer test paper was removed from the right side in the order of insertion and the left side removed. The wet length was measured in millimeters and the length of the midpoint was measured when the wet border was oblique.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Tear Film Break-up Time (TBUT)
Description
After blinking blue fluorescein staining of the cobalt blue light source, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Ocular Surface Disease Index (OSDI)
Description
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for none of the time, 1 point for some of the time, 2 points for half of the time, 3 points for most of the time, and 4 points for all of the time.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
AST or ALT levels greater than twice the upper limit of normal range
History of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery)
Within 1 year before screening, Those who have been diagnosed with alcohol or drug abuse and are receiving treatment
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)
Pregnant or lactating women
within 30 days before participating in the clinical trial, Those who have applied other clinical trial drugs or medical devices
Patients judged by other investigators as unsuitable to participate in this clinical trial
Facility Information:
Facility Name
Kukje Pharma
City
Seongnam
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome
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