Trial Outcomes & Findings for Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain (NCT NCT02793817)
NCT ID: NCT02793817
Last Updated: 2020-12-16
Results Overview
Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
COMPLETED
PHASE3
520 participants
Visit 5 (Day 8) maintained through Visit 6 (Day 15)
2020-12-16
Participant Flow
Participant milestones
| Measure |
KPI-121 1.0% Ophthalmic Suspension
dosed BID
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
259
|
|
Overall Study
COMPLETED
|
258
|
254
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Baseline characteristics by cohort
| Measure |
KPI-121 1.0% Ophthalmic Suspension
n=261 Participants
dosed BID
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 Ophthalmic Suspension
n=259 Participants
dosed BID
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
|
Total
n=520 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
69.3 years
n=7 Participants
|
68.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
446 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
261 participants
n=5 Participants
|
259 participants
n=7 Participants
|
520 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (Day 8) maintained through Visit 6 (Day 15)Population: Intent to Treat - All subjects randomized
Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Complete Resolution of Anterior Chamber (AC) Cells at Day 8
|
54 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (Day 8) maintained through Visit 6 (Day 15)Population: Intent to Treat - All subjects randomized
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Complete Resolution of Ocular Pain at Day 8
|
149 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 4) maintained through Visit 6 (Day 15)Population: Intent to Treat - All subjects randomized
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Complete Resolution of Ocular Pain at Day 4
|
109 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Visit 4 (Day 4) maintained through Visit 6 (Day 15)Population: Intent to Treat - All subjects randomized
Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None 1. = Mild (trace to clearly noticeable, visible) 2. = Moderate (without plastic aqueous humor) 3. = Marked (with plastic aqueous humor) 4. = Severe (with fibrin deposits and/or clots)
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Complete Resolution of Anterior Chamber (AC) Flare at Day 4
|
113 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline) and Visit 4 (Day 4)Population: Intent to Treat - All subjects randomized
The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=258 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=257 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
|
-0.7 score on a scale
Standard Deviation 0.84
|
-0.5 score on a scale
Standard Deviation 0.91
|
POST_HOC outcome
Timeframe: Visit 1 (Baseline) and Visit 5 (Day 8)Population: Intent to Treat - All subjects randomized
The difference in mean changes from BL in AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=258 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=257 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8
|
-1.3 score on a scale
Standard Deviation 0.90
|
-1.0 score on a scale
Standard Deviation 0.94
|
POST_HOC outcome
Timeframe: Visit 1 (Baseline) and Visit 6 (Day 15)Population: Intent to Treat - All subjects randomized
The difference in mean changes from BL in AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Outcome measures
| Measure |
KPI-121 1% Ophthalmic Suspension
n=257 Participants
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=254 Participants
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15
|
-1.8 score on a scale
Standard Deviation 0.84
|
-1.6 score on a scale
Standard Deviation 0.87
|
Adverse Events
KPI-121 1% Ophthalmic Suspension
Vehicle of KPI-121 1% Ophthalmic Suspension
Serious adverse events
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 participants at risk
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 participants at risk
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/261 • Number of events 1 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
0.00%
0/259 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/261 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
0.39%
1/259 • Number of events 1 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/261 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
0.39%
1/259 • Number of events 1 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Nervous system disorders
erebrovascular Accident
|
0.00%
0/261 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
0.39%
1/259 • Number of events 1 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
Other adverse events
| Measure |
KPI-121 1% Ophthalmic Suspension
n=261 participants at risk
KPI-121 1% Ophthalmic Suspension dosed BID
|
Vehicle of KPI-121 1% Ophthalmic Suspension
n=259 participants at risk
Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID
|
|---|---|---|
|
Eye disorders
Cystoid macular oedema
|
1.1%
3/261 • Number of events 3 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
1.2%
3/259 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Eye disorders
Eye pain
|
1.1%
3/261 • Number of events 3 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
2.3%
6/259 • Number of events 6 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Eye disorders
Posterior capsule opacification
|
1.1%
3/261 • Number of events 3 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
1.5%
4/259 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
General disorders
Instilation site pain
|
0.38%
1/261 • Number of events 2 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
1.2%
3/259 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
4/261 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
0.39%
1/259 • Number of events 1 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
|
Nervous system disorders
Headache
|
1.5%
4/261 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
1.5%
4/259 • Number of events 4 • Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No submission for publication or public disclosure will be made by the PI until after the publication of the results of the multi-center clinical trial by the Sponsor. Thereafter, PI shall provide KALA with an advance copy of any proposed publication or public disclosure at least sixty (60) days prior to the planned date of submission or disclosure and KALA shall have forty-five (45) days from the date of its receipt to recommend changes.
- Publication restrictions are in place
Restriction type: OTHER