Trial Outcomes & Findings for Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract (NCT NCT03496467)
NCT ID: NCT03496467
Last Updated: 2021-10-12
Results Overview
Assessment of pain in subjects as measured by a scale of 0 - 5. Post-op pain scale: 0 represents absence of pain and 5 represents a definite, continuous unbearable ocular or periocular pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
day 14
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
Nepafenac PPDS
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
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|---|---|---|
|
Overall Study
STARTED
|
38
|
18
|
|
Overall Study
COMPLETED
|
34
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
Baseline characteristics by cohort
| Measure |
Nepafenac PPDS
n=38 Participants
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
n=18 Participants
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
|
Total
n=56 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 7.17 • n=39 Participants
|
67.8 years
STANDARD_DEVIATION 7.64 • n=41 Participants
|
67.4 years
STANDARD_DEVIATION 7.26 • n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=39 Participants
|
18 participants
n=41 Participants
|
56 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: day 14Assessment of pain in subjects as measured by a scale of 0 - 5. Post-op pain scale: 0 represents absence of pain and 5 represents a definite, continuous unbearable ocular or periocular pain.
Outcome measures
| Measure |
Nepafenac PPDS
n=34 Participants
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
n=14 Participants
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
|
|---|---|---|
|
Assessment of Pain
no pain
|
30 Participants
|
13 Participants
|
|
Assessment of Pain
trace pain
|
2 Participants
|
0 Participants
|
|
Assessment of Pain
mild pain
|
2 Participants
|
1 Participants
|
|
Assessment of Pain
moderate pain
|
0 Participants
|
0 Participants
|
|
Assessment of Pain
severe pain
|
0 Participants
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0 Participants
|
|
Assessment of Pain
intolerable pain
|
0 Participants
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0 Participants
|
SECONDARY outcome
Timeframe: day 14Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.
Outcome measures
| Measure |
Nepafenac PPDS
n=34 Participants
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
n=14 Participants
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
|
|---|---|---|
|
Assessment of Anterior Chamber Cells
None: no cells seen
|
22 Participants
|
7 Participants
|
|
Assessment of Anterior Chamber Cells
Severe: >30 cells seen
|
0 Participants
|
0 Participants
|
|
Assessment of Anterior Chamber Cells
Trace: 1-5 cells seen
|
7 Participants
|
3 Participants
|
|
Assessment of Anterior Chamber Cells
Mild: 6-15 cells seen
|
5 Participants
|
4 Participants
|
|
Assessment of Anterior Chamber Cells
Moderate: 16-30 cells seen
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 14Anterior chamber flare is assessed using a scale of 0 - 4 with 0 representing no Tyndall effect and 4 representing Tyndall effect in anterior chamber is very intense
Outcome measures
| Measure |
Nepafenac PPDS
n=34 Participants
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
n=14 Participants
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
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|---|---|---|
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Assessment of Flare
None: No Tyndall effect
|
29 Participants
|
10 Participants
|
|
Assessment of Flare
Trace: Tyndall effect barely discernible
|
3 Participants
|
1 Participants
|
|
Assessment of Flare
Mild: Tyndall effect in anterior chamber is clearly visible
|
2 Participants
|
3 Participants
|
|
Assessment of Flare
Moderate: Tyndall effect in anterior chamber is moderately intense
|
0 Participants
|
0 Participants
|
|
Assessment of Flare
Severe: Tyndall effect in anterior chamber is very intense. The aqueous has a white milky appearance
|
0 Participants
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0 Participants
|
Adverse Events
Nepafenac PPDS
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo PPDS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nepafenac PPDS
n=38 participants at risk
N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
|
Placebo PPDS
n=18 participants at risk
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Placebo PPDS: A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
|
|---|---|---|
|
Eye disorders
elevated IOP
|
7.9%
3/38 • Number of events 3 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
0.00%
0/18 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
|
Eye disorders
iritis
|
5.3%
2/38 • Number of events 2 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
5.6%
1/18 • Number of events 1 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Number of events 1 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
5.6%
1/18 • Number of events 1 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
|
Eye disorders
posterior capsule rupture
|
0.00%
0/38 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
5.6%
1/18 • Number of events 1 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
|
General disorders
Cavity, 3rd molar
|
2.6%
1/38 • Number of events 1 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
0.00%
0/18 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
|
Eye disorders
Pain/irritation/inflammation
|
7.9%
3/38 • Number of events 3 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
0.00%
0/18 • The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op
Subjects were asked: "Have you had any problems since your last visit?"
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place