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

NCT05017844 | Completed Phase 2 DMC

• 1 other identifier: KSR-001-P02
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 12 weeks

Secondary Outcomes (5)

• Fluorescein Corneal Staining (FCS)

  Baseline, 4 weeks, 8 weeks

• Lissamine Green Conjunctival Staining (LGCS)

  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

• Ocular Surface Disease Index (OSDI)

  Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (3)

KSR-001-04

PLACEBO COMPARATOR

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

Drug: KSR-001-04

KSR-001-02

EXPERIMENTAL

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

Drug: KSR-001-02

KSR-001-03

EXPERIMENTAL

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

Drug: KSR-001-03

Interventions

KSR-001-04 DRUG

One drop to both eyes four times a day for 12 weeks

KSR-001-04

KSR-001-02 DRUG

One drop to both eyes four times a day for 12 weeks

KSR-001-02

KSR-001-03 DRUG

One drop to both eyes four times a day for 12 weeks

KSR-001-03

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kukje Pharma: lead
• Samil Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Kukje Pharma

Seongnam, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: February 18, 2020
• Primary Completion: February 8, 2021
• Study Completion: June 22, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)