[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome

Kukje Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: KSR-001-04; Drug: KSR-001-02; Drug: KSR-001-03

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05017844

KSR-001-P02

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome

Enrollment: 222 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 3 patient groups, including a placebo group

KSR-001-04

Placebo Comparator group

Description:

KSR-001-04 eyedrops recieved one drop to both eyes four times a day for 12 weeks.

Treatment:

Drug: KSR-001-04

KSR-001-02

Experimental group

Description:

KSR-001-02 eyedrops recieved one drop to both eyes four times a day for 12 weeks.

Treatment:

Drug: KSR-001-02

KSR-001-03

Experimental group

Description:

KSR-001-03 eyedrops recieved one drop to both eyes four times a day for 12 weeks.

Treatment:

Drug: KSR-001-03