Trial Outcomes & Findings for A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease (NCT NCT04084483)
NCT ID: NCT04084483
Last Updated: 2023-03-15
Results Overview
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining. K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.
COMPLETED
PHASE2
238 participants
Baseline to Day 29
2023-03-15
Participant Flow
During the screening period, two 90-minute exposures to the CAE® were conducted to ascertain eligibility to enter the study. Participants who qualified after the initial screening visit entered the run-in phase, where they self-administered Vehicle for approximately 14 days. Those who qualified at Visit 2 (Day 1) were randomized to receive study drug in a double-masked fashion for 28 days.
Participant milestones
| Measure |
Placebo (BID) (Vehicle)
1 drop Ophthalmic Solution
|
0.025% K-161 (BID)
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
1 drop Ophthalmic Solution
|
0.1% K-161 (QID)
1 drop Ophthalmic Solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
61
|
59
|
|
Overall Study
COMPLETED
|
56
|
57
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.025% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (QID)
n=59 Participants
1 drop Ophthalmic Solution
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Age, Customized
≥ 65 years
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-CAE)
|
3.30 scores on a scale
STANDARD_DEVIATION 0.361 • n=5 Participants
|
3.36 scores on a scale
STANDARD_DEVIATION 0.405 • n=7 Participants
|
3.35 scores on a scale
STANDARD_DEVIATION 0.412 • n=5 Participants
|
3.33 scores on a scale
STANDARD_DEVIATION 0.378 • n=4 Participants
|
3.33 scores on a scale
STANDARD_DEVIATION 0.388 • n=21 Participants
|
|
Ocular Discomfort Scale Post-CAE
|
3.8 scores on a scale
STANDARD_DEVIATION 0.49 • n=5 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 0.48 • n=7 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
3.6 scores on a scale
STANDARD_DEVIATION 0.72 • n=4 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 0.58 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining. K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
|
-0.57 scores on a scale
Standard Error 0.075
|
-0.44 scores on a scale
Standard Error 0.073
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID
Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Ocular Discomfort Scale Post-CAE
|
0.0 score on a scale
Standard Error 0.06
|
0.0 score on a scale
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID
Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE
|
3.4 mm
Standard Error 0.85
|
2.2 mm
Standard Error 0.80
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Tear Film Break-up Time (TFBUT) Post-CAE
|
0.402 Seconds
Standard Error 0.1090
|
0.132 Seconds
Standard Error 0.1049
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Fluorescein Staining Scores (Pre-CAE®)
Corneal Sum
|
-0.28 score on a scale
Standard Error 0.184
|
-0.36 score on a scale
Standard Error 0.182
|
-0.50 score on a scale
Standard Error 0.178
|
|
Change in Fluorescein Staining Scores (Pre-CAE®)
Conjunctival Sum
|
-0.03 score on a scale
Standard Error 0.138
|
-0.22 score on a scale
Standard Error 0.136
|
-0.28 score on a scale
Standard Error 0.133
|
|
Change in Fluorescein Staining Scores (Pre-CAE®)
Total Eye Sum
|
-0.30 score on a scale
Standard Error 0.292
|
-0.59 score on a scale
Standard Error 0.290
|
-0.80 score on a scale
Standard Error 0.283
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
|
-0.16 score on a scale
Standard Error 0.132
|
-0.25 score on a scale
Standard Error 0.131
|
-0.39 score on a scale
Standard Error 0.127
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Conjunctival Redness Scale ranges from 0 to 4, where 0 = normal, without vasodilation and 4 = Broad Ciliary and Prominent, Horizontal Conjunctival Vasodilation. Higher scores indicate worsening conjunctival redness.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Conjunctival Redness (Pre-CAE)
|
-0.21 Point
Standard Error 0.061
|
-0.20 Point
Standard Error 0.060
|
-0.22 Point
Standard Error 0.059
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Tear Film Break-Up Time (Pre CAE)
|
0.312 Seconds
Standard Error 0.0880
|
0.398 Seconds
Standard Error 0.0863
|
0.242 Seconds
Standard Error 0.0848
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Tear Osmolarity (Pre CAE)
|
-0.5 mOsm/L
Standard Error 2.17
|
1.0 mOsm/L
Standard Error 2.09
|
0.4 mOsm/L
Standard Error 2.03
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Unanesthetized Schirmer's Test (Pre CAE)
|
3.3 mm
Standard Error 0.82
|
3.1 mm
Standard Error 0.80
|
2.1 mm
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Blinks per 60 seconds.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Blink Rate (Pre CAE)
|
0.1 Blinks per 60 seconds
Standard Error 1.41
|
0.1 Blinks per 60 seconds
Standard Error 1.39
|
-0.2 Blinks per 60 seconds
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Ocular Discomfort Scale (Pre CAE)
|
-0.3 Score
Standard Error 0.13
|
-0.2 Score
Standard Error 0.13
|
-0.5 Score
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Ocular Discomfort
|
-0.2 Point
Standard Error 0.13
|
-0.2 Point
Standard Error 0.13
|
-0.4 Point
Standard Error 0.13
|
|
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Burning
|
0.1 Point
Standard Error 0.13
|
0.0 Point
Standard Error 0.13
|
-0.1 Point
Standard Error 0.13
|
|
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Dryness
|
-0.1 Point
Standard Error 0.14
|
-0.2 Point
Standard Error 0.14
|
-0.3 Point
Standard Error 0.13
|
|
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Grittiness
|
-0.1 Point
Standard Error 0.15
|
-0.3 Point
Standard Error 0.15
|
-0.1 Point
Standard Error 0.15
|
|
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Stinging
|
-0.1 Point
Standard Error 0.15
|
-0.1 Point
Standard Error 0.15
|
-0.2 Point
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
The length of the assessment line was 100 mm; a measure of 0 mm corresponded to "no discomfort" and 100 mm corresponds to "maximal discomfort".
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Visual Analog Scale (Pre CAE)
Burning/Stinging
|
-1.9 mm
Standard Error 2.78
|
-7.6 mm
Standard Error 2.76
|
-5.6 mm
Standard Error 2.68
|
|
Change in Visual Analog Scale (Pre CAE)
Itching
|
-3.1 mm
Standard Error 2.92
|
-9.7 mm
Standard Error 2.92
|
-6.1 mm
Standard Error 2.84
|
|
Change in Visual Analog Scale (Pre CAE)
Foreign Body Sensation
|
-1.1 mm
Standard Error 2.96
|
-6.9 mm
Standard Error 2.94
|
-5.6 mm
Standard Error 2.82
|
|
Change in Visual Analog Scale (Pre CAE)
Blurry Vision
|
-0.2 mm
Standard Error 2.69
|
-5.5 mm
Standard Error 2.67
|
-7.5 mm
Standard Error 2.60
|
|
Change in Visual Analog Scale (Pre CAE)
Eye Dryness
|
-4.1 mm
Standard Error 2.71
|
-6.1 mm
Standard Error 2.68
|
-10.7 mm
Standard Error 2.60
|
|
Change in Visual Analog Scale (Pre CAE)
Photophobia
|
-2.8 mm
Standard Error 2.78
|
-6.2 mm
Standard Error 2.75
|
-10.7 mm
Standard Error 2.67
|
|
Change in Visual Analog Scale (Pre CAE)
Pain
|
0.0 mm
Standard Error 2.37
|
-6.0 mm
Standard Error 2.37
|
-4.2 mm
Standard Error 2.28
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID
The OSDI© is comprised of 12 questions, with each question assessed on a scale ranging from 0 to 4 where 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time. The range of total score is "0 to 100". "Subscale" scores are not reported. Higher score represents a worsen outcome. The total score is the sum of subscales.
Outcome measures
| Measure |
Placebo (BID) (Vehicle)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=59 Participants
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 Participants
1 drop Ophthalmic Solution
|
|---|---|---|---|
|
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI
|
-3.2 scores on a scale
Standard Error 2.03
|
-2.9 scores on a scale
Standard Error 2.00
|
-7.8 scores on a scale
Standard Error 1.95
|
Adverse Events
Placebo (BID) (Vehicle)
0.025% K-161 (BID)
0.1% K-161 (BID)
0.1% K-161 (QID)
Serious adverse events
| Measure |
Placebo (BID) (Vehicle)
n=59 participants at risk
1 drop Ophthalmic Solution
|
0.025% K-161 (BID)
n=59 participants at risk
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 participants at risk
1 drop Ophthalmic Solution
|
0.1% K-161 (QID)
n=59 participants at risk
1 drop Ophthalmic Solution
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Nervous system disorders
Toxic encephalopathy
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
Other adverse events
| Measure |
Placebo (BID) (Vehicle)
n=59 participants at risk
1 drop Ophthalmic Solution
|
0.025% K-161 (BID)
n=59 participants at risk
1 drop Ophthalmic Solution
|
0.1% K-161 (BID)
n=61 participants at risk
1 drop Ophthalmic Solution
|
0.1% K-161 (QID)
n=59 participants at risk
1 drop Ophthalmic Solution
|
|---|---|---|---|---|
|
General disorders
Instillation site pain
|
3.4%
2/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
10.2%
6/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
37.7%
23/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
35.6%
21/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
1.7%
1/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
3.3%
2/61 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
5.1%
3/59 • 36 Days
Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
Additional Information
Director, Clinical Operations
Kowa Research Institute, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place