Trial Outcomes & Findings for Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (NCT NCT02163824)
NCT ID: NCT02163824
Last Updated: 2021-01-29
Results Overview
Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. 0= No cells seen 1. 1 to 5 cells 2. 6 to 15 cells 3. 16 to 30 cells 4. greater than 30 cells
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
KPI-121 0.25% QID
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
129
|
125
|
126
|
|
Overall Study
COMPLETED
|
127
|
124
|
124
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Baseline characteristics by cohort
| Measure |
KPI-121 0.25% QID
n=129 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=126 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.4 years
n=5 Participants
|
67.9 years
n=7 Participants
|
69.8 years
n=5 Participants
|
68.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
125 participants
n=7 Participants
|
126 participants
n=5 Participants
|
380 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)Population: Intent to treat- all subjects randomized
Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. 0= No cells seen 1. 1 to 5 cells 2. 6 to 15 cells 3. 16 to 30 cells 4. greater than 30 cells
Outcome measures
| Measure |
KPI-121 0.25% QID
n=129 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=126 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Resolution of Anterior Chamber Cells
|
48 Participants
|
39 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)Population: Intent to Treat- all subjects randomized.
Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.
Outcome measures
| Measure |
KPI-121 0.25% QID
n=129 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=126 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Resolution of Ocular Pain
|
73 Participants
|
67 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Visit 5 (postoperative 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.
Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 5/Day 8. The difference in mean grade of AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). 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 0.25% QID
n=128 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=125 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Anterior Chamber Cell Grade at Visit 5.
|
0.7 score on a scale
Standard Deviation 0.73
|
0.9 score on a scale
Standard Deviation 0.74
|
1.0 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Visit 6 (postoperative 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.
Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 6/Day 15. The difference in mean grade of AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). 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 0.25% QID
n=127 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=124 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=124 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Anterior Chamber Cell Grade at Visit 6.
|
0.4 score on a scale
Standard Deviation .65
|
0.5 score on a scale
Standard Deviation .69
|
0.6 score on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: Visit 5 (postoperative 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.
Mean Grade of Ocular Pain (Scale 0-5) at Visit 5/Day 8. The difference in mean grade of ocular pain grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain. 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 0.25% QID
n=128 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=125 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Ocular Pain Grades at Day 8.
|
0.4 score on a scale
Standard Deviation 0.74
|
0.4 score on a scale
Standard Deviation 0.64
|
0.5 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Visit 6 (postoperative 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.
Mean Grade of Ocular Pain (Scale 0-5) at Visit 6/Day 15. The difference in mean grade of ocular pain grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain. 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 0.25% QID
n=127 Participants
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=124 Participants
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=124 Participants
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Ocular Pain Grades at Day 15.
|
0.2 score on a scale
Standard Deviation 0.50
|
0.2 score on a scale
Standard Deviation 0.51
|
0.3 score on a scale
Standard Deviation 0.73
|
Adverse Events
KPI-121 0.25% QID
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
KPI-121 1.0% BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Vehicle of KPI-121
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KPI-121 0.25% QID
n=129 participants at risk
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 participants at risk
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=126 participants at risk
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.78%
1/129 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/126 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
General disorders
Chest pain
|
0.78%
1/129 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/126 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/129 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.80%
1/125 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/126 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/129 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/129 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
Other adverse events
| Measure |
KPI-121 0.25% QID
n=129 participants at risk
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 0.25%: 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.
|
KPI-121 1.0% BID
n=125 participants at risk
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
KPI-121 1.0%: KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
|
Vehicle of KPI-121
n=126 participants at risk
Vehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily or 1.0% Ophthalmic Suspension dose 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Vehicle of KPI-121: Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
|
|---|---|---|---|
|
Eye disorders
eye pain
|
1.6%
2/129 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.80%
1/125 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
4.0%
5/126 • Number of events 5 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
photophobia
|
2.3%
3/129 • Number of events 3 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.80%
1/125 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
2.4%
3/126 • Number of events 3 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
punctate keratitis
|
2.3%
3/129 • Number of events 3 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.80%
1/125 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/126 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
eye inflammation
|
1.6%
2/129 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
3.2%
4/126 • Number of events 4 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
ocular discomfort
|
0.00%
0/129 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
1.6%
2/126 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
ocular hyperaemia
|
0.00%
0/129 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.00%
0/125 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
4.0%
5/126 • Number of events 5 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Nervous system disorders
headache
|
0.78%
1/129 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
1.6%
2/125 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
2.4%
3/126 • Number of events 3 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
eye irritation
|
0.78%
1/129 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
0.80%
1/125 • Number of events 1 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
2.4%
3/126 • Number of events 3 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
|
Eye disorders
corneal oedema
|
1.6%
2/129 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
1.6%
2/125 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
1.6%
2/126 • Number of events 2 • Adverse events were collected from the time subjects signed the informed consent until they exited the study at the end of Visit 7 (up to Day 19).
|
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