Trial Outcomes & Findings for Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (NCT NCT02188160)
NCT ID: NCT02188160
Last Updated: 2021-01-06
Results Overview
Comparison of mean bulbar conjunctival hyperemia in the study eye 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Visit 6 (Day 29)
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
77
|
|
Overall Study
COMPLETED
|
72
|
76
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Use of an excluded medication
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 17.17 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 12.29 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
117 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
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
77 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 6 (Day 29)Population: ITT
Comparison of mean bulbar conjunctival hyperemia in the study eye 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=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Bulbar Conjunctival Hyperemia
|
1.22 score on a scale
Standard Deviation 0.633
|
1.36 score on a scale
Standard Deviation 0.626
|
PRIMARY outcome
Timeframe: Visit 6 (Day 29)Population: ITT
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=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Ocular Discomfort
|
57.05 score on a scale
Standard Deviation 23.892
|
60.47 score on a scale
Standard Deviation 19.770
|
SECONDARY outcome
Timeframe: Visit 4 (Day 15) and Visit 6 (Day 29)Population: ITT
Comparison of mean corneal fluorescein staining scores in the study eye 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. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15.
Outcome measures
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Corneal Fluorescein Staining Scores
Visit 4 (Day 15)
|
6.15 score on a scale
Standard Deviation 2.582
|
7.00 score on a scale
Standard Deviation 2.920
|
|
Corneal Fluorescein Staining Scores
Visit 6 (Day 29)
|
5.64 score on a scale
Standard Deviation 2.889
|
6.16 score on a scale
Standard Deviation 3.445
|
SECONDARY outcome
Timeframe: Visit 4 (Day 15)Population: ITT
Comparison of mean bulbar conjunctival hyperemia scores in the study eye 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=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Bulbar Conjunctival Hyperemia Scores
|
1.36 score on a scale
Standard Deviation 0.586
|
1.42 score on a scale
Standard Deviation 0.676
|
SECONDARY outcome
Timeframe: Visit 4 (Day 15)Population: ITT
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=73 Participants
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Ocular Discomfort
|
58.83 score on a scale
Standard Deviation 20.745
|
63.63 score on a scale
Standard Deviation 17.844
|
Adverse Events
KPI-121 0.25% Ophthalmic Suspension
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=72 participants at risk
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=78 participants at risk
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/72 • Number of events 1 • Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).
One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.
|
0.00%
0/78 • Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).
One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.
|
Other adverse events
| Measure |
KPI-121 0.25% Ophthalmic Suspension
n=72 participants at risk
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
KPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle
n=78 participants at risk
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
Placebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|
|
General disorders
Instillation site pain
|
9.7%
7/72 • Number of events 18 • Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).
One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.
|
10.3%
8/78 • Number of events 16 • Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).
One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution and Investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER