A Study to Confirm the Efficacy and Safety of K-161 Ophth... | NCT05403827

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
K-161	Experimental	K-161 Ophthalmic Solution	Drug: K-161
Placebo	Placebo Comparator	Vehicle Solution	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
K-161	Drug	K-161 Ophthalmic Solution	K-161
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in EDS (VAS) From Baseline to Day 85	Eye Dryness Score (EDS) on Visual analog scale (VAS) Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".	Baseline to Day 85
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)	Assessed by expanded National Eye Institute (NEI) scale Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed) Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.	Baseline to Day 85

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)	Assessed by expanded National Eye Institute (NEI) scale. Total eye sum will be assessed as the sum of Corneal sum fluorescein staining score and conjunctival sum fluorescein staining score. Minimum is 0 and maximum is 44 for Total Eye Sum Fluorescein Staining Score.	Baseline to Day 85

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Andrey E. Belous, MD, PhD	Kowa Pharma Development Co.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center		Birmingham	Alabama	35294	United States

Results Section

Participant Flow Module

ID	Title	Description
FG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
FG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Initial	Nov 22, 2021	Dec 16, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
BG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.9± 13.88 BG00160.0± 15.18 BG00260.0± 14.54

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000233 BG001234 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000234 BG001230 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in EDS (VAS) From Baseline to Day 85

Eye Dryness Score (EDS) on Visual analog scale (VAS)
Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".

The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:

• Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.

Posted

Mean

Standard Deviation

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000292 OG001306

Title

Denominators

Categories

Title	Measurements
	OG000-18.0± 25.10 OG001-19.4± 25.34

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Control-Based Mean Imputation		0.5019														Superiority

Primary

Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)

Assessed by expanded National Eye Institute (NEI) scale
Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed)
Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)

Assessed by expanded National Eye Institute (NEI) scale.
Total eye sum will be assessed as the sum of Corneal sum fluorescein staining score and conjunctival sum fluorescein staining score.
Minimum is 0 and maximum is 44 for Total Eye Sum Fluorescein Staining Score.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)

Assessed by expanded National Eye Institute (NEI) scale.
Corneal sum will be assessed as the sum of points in 5 corneal zones, and each zone will be graded on a 5-point scale from 0 - no punctate stain in the area to 4 - Severe diffuse (coalescent) macropunctate stain of the area (0.5 increments would be allowed)
Minimum is 0 and maximum is 20 for Corneal Sum Fluorescein Staining Score

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Secondary

OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

Posted

Mean

Standard Deviation

Score on a scale

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)

Length (mm) of the moistened area assessed by inserting a Schirmer test strip into the eye for 5 minutes to measure the production of tears.

Posted

Mean

Standard Deviation

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)

The time (in seconds) taken for the first dry spot to appear on the cornea after a complete blink (with the aid of a slit-lamp).

Posted

Mean

Standard Deviation

Seconds

Baseline to Day 85

ID	Title	Description
OG000	K-161	K-161 topical Ophthalmic solution for 12 weeks
OG001	Vehicle	Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	K-161 12-Week	The safety population included all participants treated in the 12-Week primary period (SP12) who received K-161 ophthalmic solution.	321	3	321	32	321
EG001	Vehicle 12-Week	The safety population included all participants treated in the 12-Week primary period (SP12) who received vehicle solution.	322	2	322	0	322
EG002	K-161 40-Week Extension	The analysis group consist of only subjects from the 40-Week extension period assigned to receive K-161 ophthalmic solution.	122	1	122	0	122
EG003	Vehicle 40-Week Extension	The analysis group consist of only subjects from the 40-Week extension period assigned to receive Vehicle ophthalmic solution.	121	2	121	0	121

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA v25.0	Systematic Assessment	EG0001 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG0030 affected121 at risk
Urinary tract infection	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0001 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG003
Appendicitis	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0000 affected321 at risk EG0011 affected322 at risk EG0020 affected122 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA v25.0	Systematic Assessment	EG0000 affected321 at risk EG0011 affected322 at risk EG0020 affected122 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.0	Systematic Assessment	EG0001 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG003
Allergy to arthropod sting	Immune system disorders	MedDRA v25.0	Systematic Assessment	EG0000 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG003
Rectal abscess	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0000 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA v25.0	Systematic Assessment	EG0000 affected321 at risk EG0010 affected322 at risk EG0021 affected122 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Instillation site pain	General disorders	MedDRA v25.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG00032 affected321 at risk EG0010 affected322 at risk EG0020 affected122 at risk EG0030 affected121 at risk

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases