Trial Outcomes & Findings for A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease (NCT NCT05403827)
NCT ID: NCT05403827
Last Updated: 2025-01-14
Results Overview
* 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".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
644 participants
Primary outcome timeframe
Baseline to Day 85
Results posted on
2025-01-14
Participant Flow
At Visit 1 (Screening), eligible participants were provided single-masked run-in product (Vehicle) for self-administration in the morning and evening, for approximately 14 days. At Visit 2 (Baseline), participants who remained eligible for the study were randomized in a 1:1 ratio to double-masked IP (K-161 or Vehicle). Each participant provided voluntary informed consent before any study-specific assessments or procedures were performed.
Participant milestones
| Measure |
K-161
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
12 Week Primary
STARTED
|
322
|
322
|
|
12 Week Primary
COMPLETED
|
253
|
269
|
|
12 Week Primary
NOT COMPLETED
|
69
|
53
|
|
52 Week Overall
STARTED
|
122
|
121
|
|
52 Week Overall
COMPLETED
|
67
|
75
|
|
52 Week Overall
NOT COMPLETED
|
55
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Baseline characteristics by cohort
| Measure |
K-161
n=321 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=322 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 13.88 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 15.18 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
234 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 85Population: 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.
* 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".
Outcome measures
| Measure |
K-161
n=292 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change in EDS (VAS) From Baseline to Day 85
|
-18.0 mm
Standard Deviation 25.10
|
-19.4 mm
Standard Deviation 25.34
|
PRIMARY outcome
Timeframe: Baseline to Day 85* 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.
Outcome measures
| Measure |
K-161
n=291 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)
|
-2.81 Score on a scale
Standard Deviation 3.661
|
-3.25 Score on a scale
Standard Deviation 3.480
|
SECONDARY outcome
Timeframe: Baseline to Day 85* 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.
Outcome measures
| Measure |
K-161
n=291 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)
|
-4.73 Score on a scale
Standard Deviation 5.693
|
-5.44 Score on a scale
Standard Deviation 5.546
|
SECONDARY outcome
Timeframe: Baseline to Day 85* 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
Outcome measures
| Measure |
K-161
n=291 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)
|
-1.92 Score on a scale
Standard Deviation 2.905
|
-2.19 Score on a scale
Standard Deviation 2.841
|
SECONDARY outcome
Timeframe: Baseline to Day 85OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
Outcome measures
| Measure |
K-161
n=292 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)
|
-14.12 Score on a scale
Standard Deviation 17.099
|
-14.17 Score on a scale
Standard Deviation 17.594
|
SECONDARY outcome
Timeframe: Baseline to Day 85Length (mm) of the moistened area assessed by inserting a Schirmer test strip into the eye for 5 minutes to measure the production of tears.
Outcome measures
| Measure |
K-161
n=291 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=306 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)
|
2.4 mm
Standard Deviation 5.47
|
2.6 mm
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: Baseline to Day 85The 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).
Outcome measures
| Measure |
K-161
n=291 Participants
K-161 topical Ophthalmic solution for 12 weeks
|
Vehicle
n=305 Participants
Vehicle K-161 identical topical ophthalmic solution without active drug for 12 weeks
|
|---|---|---|
|
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)
|
0.580 Seconds
Standard Deviation 1.2089
|
0.520 Seconds
Standard Deviation 1.1989
|
Adverse Events
K-161 12-Week
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Vehicle 12-Week
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
K-161 40-Week Extension
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle 40-Week Extension
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
K-161 12-Week
n=321 participants at risk
The safety population included all participants treated in the 12-Week primary period (SP12) who received K-161 ophthalmic solution.
|
Vehicle 12-Week
n=322 participants at risk
The safety population included all participants treated in the 12-Week primary period (SP12) who received vehicle solution.
|
K-161 40-Week Extension
n=122 participants at risk
The analysis group consist of only subjects from the 40-Week extension period assigned to receive K-161 ophthalmic solution.
|
Vehicle 40-Week Extension
n=121 participants at risk
The analysis group consist of only subjects from the 40-Week extension period assigned to receive Vehicle ophthalmic solution.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Infections and infestations
Urinary tract infection
|
0.31%
1/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.31%
1/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.31%
1/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.31%
1/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.83%
1/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.83%
1/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.82%
1/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
Other adverse events
| Measure |
K-161 12-Week
n=321 participants at risk
The safety population included all participants treated in the 12-Week primary period (SP12) who received K-161 ophthalmic solution.
|
Vehicle 12-Week
n=322 participants at risk
The safety population included all participants treated in the 12-Week primary period (SP12) who received vehicle solution.
|
K-161 40-Week Extension
n=122 participants at risk
The analysis group consist of only subjects from the 40-Week extension period assigned to receive K-161 ophthalmic solution.
|
Vehicle 40-Week Extension
n=121 participants at risk
The analysis group consist of only subjects from the 40-Week extension period assigned to receive Vehicle ophthalmic solution.
|
|---|---|---|---|---|
|
General disorders
Instillation site pain
|
10.0%
32/321 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/322 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/122 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
0.00%
0/121 • 52 Weeks
Treatment emergent adverse events (TEAEs) were defined as AEs that began after the start of the double-masked IP dosing, or events that began before the start of the double-masked IP dosing and worsened in intensity after IP dosing began.
|
Additional Information
Director, Clinical Operations
Kowa Research Institute, Inc.
Phone: 919-433-1600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee INSTITUTION/INVESTIGATOR may publish/present results after SPONSOR publication. Prior SPONSOR review protects confidential info \& patentable material. Confidential info will be removed. Patentable findings may delay publication for patent filing. Acknowledgement of SPONSOR's support is at SPONSOR's option, with prior consent required for any SPONSOR reference.
- Publication restrictions are in place
Restriction type: OTHER