Trial Outcomes & Findings for Safety and Efficacy of KPI-121 in Subjects With DED (NCT NCT03616899)
NCT ID: NCT03616899
Last Updated: 2021-04-02
Results Overview
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
901 participants
Primary outcome timeframe
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Results posted on
2021-04-02
Participant Flow
901 subjects were randomized and all were included in the ITT population.
Participant milestones
| Measure |
KPI-121 0.25% Ophthalmic Suspension
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Overall Study
STARTED
|
447
|
454
|
|
Overall Study
COMPLETED
|
437
|
453
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of KPI-121 in Subjects With DED
Baseline characteristics by cohort
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=447 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=454 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
Total
n=901 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 15.26 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 15.53 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 15.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
339 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
669 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
63 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
348 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
689 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
447 participants
n=5 Participants
|
454 participants
n=7 Participants
|
901 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=434 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=451 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
|
-13.58 score on a scale
Standard Deviation 19.379
|
-8.91 score on a scale
Standard Deviation 17.579
|
PRIMARY outcome
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)Population: Sub-group of Intent to Treat population with more severe ocular discomfort minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=296 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=304 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort
|
-15.59 score on a scale
Standard Deviation 20.373
|
-10.15 score on a scale
Standard Deviation 18.739
|
SECONDARY outcome
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed
Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=432 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=449 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
|
-0.35 score on a scale
Standard Deviation 0.575
|
-0.18 score on a scale
Standard Deviation 0.546
|
SECONDARY outcome
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed
Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=437 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=453 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor
|
-0.61 score on a scale
Standard Deviation 0.646
|
-0.48 score on a scale
Standard Deviation 0.657
|
SECONDARY outcome
Timeframe: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=443 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=453 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)
|
-8.05 score on a scale
Standard Deviation 15.009
|
-5.83 score on a scale
Standard Deviation 15.176
|
SECONDARY outcome
Timeframe: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed
Comparison of mean corneal fluorescein staining between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=437 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=453 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
|
-0.53 score on a scale
Standard Deviation 0.800
|
-0.43 score on a scale
Standard Deviation 0.739
|
SECONDARY outcome
Timeframe: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=439 Participants
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=452 Participants
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean
|
-11.76 score on a scale
Standard Deviation 18.035
|
-7.91 score on a scale
Standard Deviation 16.298
|
Adverse Events
KPI-121 0.25% Ophthalmic Suspension
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=449 participants at risk
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=452 participants at risk
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Cardiac disorders
Atrioventricular Block
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
Other adverse events
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=449 participants at risk
KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension
|
Vehicle of KPI-121 0.25% Ophthalmic Suspension
n=452 participants at risk
Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension
|
|---|---|---|
|
Eye disorders
Eye irritation
|
0.45%
2/449 • Number of events 3 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Vision blurred
|
0.45%
2/449 • Number of events 2 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Dry eye
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.66%
3/452 • Number of events 3 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
General disorders
Instillation site pain
|
2.9%
13/449 • Number of events 13 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
1.5%
7/452 • Number of events 7 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Eye pruritus
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.66%
3/452 • Number of events 3 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Investigations
Blood pressure increased
|
0.45%
2/449 • Number of events 2 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Nervous system disorders
Headache
|
0.45%
2/449 • Number of events 2 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.45%
2/449 • Number of events 2 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
General disorders
Instillation site discharge
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
General disorders
Instillation site pruritus
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Corneal infiltrates
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Eye pain
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Foreign body sensation in eyes
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
keratitis
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Ocular hypaeremia
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Photophobia
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Scleral hyperaemia
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Blepharitis
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Cataract
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Blepharospasm
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Conjunctival heamorrhage
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Conjunctival vascular disorder
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Eye discharge
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Eyelid pain
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Growth of eyelashes
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Trichiasis
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Visual impairment
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Bronchitis
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Ear infection
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Rhinitis
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Influenza
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Infections and infestations
Viral infection
|
0.00%
0/449 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Nervous system disorders
Migraine
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Nervous system disorders
Sinus headache
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Cardiac disorders
Palpitations
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.22%
1/452 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Eye disorders
Vertigo
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/449 • Number of events 1 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
0.00%
0/452 • Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following: (a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.
- Publication restrictions are in place
Restriction type: OTHER