Trial Outcomes & Findings for Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease (NCT NCT02218489)
NCT ID: NCT02218489
Last Updated: 2021-01-11
Results Overview
Comparison of change from baseline in ocular discomfort 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 at Visit 4 (Day 15).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
Visit 2 (Day 1) to Visit 4 (Day 15)
Results posted on
2021-01-11
Participant Flow
206 subjects were randomized, 1 of which were not included in any analysis population as the individual did not receive randomized treatment.
Participant milestones
| Measure |
Vehicle
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
104
|
|
Overall Study
COMPLETED
|
96
|
101
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Vehicle
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Baseline characteristics by cohort
| Measure |
Vehicle
n=101 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm 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=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 13.13 • n=99 Participants
|
60.2 years
STANDARD_DEVIATION 11.28 • n=107 Participants
|
59.4 years
STANDARD_DEVIATION 12.22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=99 Participants
|
104 participants
n=107 Participants
|
205 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)Population: ITT population
Comparison of change from baseline in ocular discomfort 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 at Visit 4 (Day 15).
Outcome measures
| Measure |
Vehicle
n=101 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Ocular Discomfort
|
-4.1 score on a scale
Standard Deviation 13.8
|
-2.4 score on a scale
Standard Deviation 16.7
|
PRIMARY outcome
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)Population: m1ITT- a subset of the ITT population with greater baseline hyperemia
Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal 1. mild 2. moderate 3. severe 4. very severe
Outcome measures
| Measure |
Vehicle
n=77 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=79 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
|
-0.5 score on a scale
Standard Deviation 0.7
|
-04 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)Population: ITT population
Comparison of change from baseline in ocular discomfort 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 at Visit 6 (Day 29).
Outcome measures
| Measure |
Vehicle
n=101 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Ocular Discomfort
|
-8.2 score on a scale
Standard Deviation 17.1
|
-5.0 score on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)Population: m1ITT- a subset of the ITT population with greater baseline hyperemia. m1ITT 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 change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal 1. mild 2. moderate 3. severe 4. very severe
Outcome measures
| Measure |
Vehicle
n=76 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=79 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
|
-0.4 score on a scale
Standard Deviation 0.7
|
-0.6 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)Population: ITT population
Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal 1. mild 2. moderate 3. severe 4. very severe
Outcome measures
| Measure |
Vehicle
n=101 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Posterior Lid Margin Hyperemia
|
-0.56 score on a scale
Standard Deviation 0.72
|
-0.55 score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)Population: ITT population
Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal 1. mild 2. moderate 3. severe 4. very severe
Outcome measures
| Measure |
Vehicle
n=101 Participants
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 Participants
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
Change From Baseline in Posterior Lid Margin Hyperemia
|
-0.63 score on a scale
Standard Deviation 0.76
|
-0.65 score on a scale
Standard Deviation 0.8
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
KPI-121 0.25% Ophthalmic Suspension
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle
n=101 participants at risk
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
|
KPI-121 0.25% Ophthalmic Suspension
n=104 participants at risk
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
|---|---|---|
|
General disorders
Instillation site pain
|
7.9%
8/101 • Number of events 8 • Adverse events were collected from the time a subject signed the informed consent at Visit 1 until they exited the study at Visit 6.
|
7.7%
8/104 • Number of events 8 • Adverse events were collected from the time a subject signed the informed consent at Visit 1 until they exited the study at Visit 6.
|
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