Trial Outcomes & Findings for Confirmatory Study Nepafenac 0.3% (NCT NCT01109173)
NCT ID: NCT01109173
Last Updated: 2012-11-30
Results Overview
Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2120 participants
Primary outcome timeframe
Day 14
Results posted on
2012-11-30
Participant Flow
Patients were randomized from 65 sites in 5 countries: US (49), Hungary (6), Italy (4), Sweden (4), and Switzerland (2).
Of the 2120 enrolled participants, 78 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least 1 postoperative assessment (ITT): 2022.
Participant milestones
| Measure |
Nepafenac 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
851
|
845
|
211
|
213
|
|
Overall Study
COMPLETED
|
763
|
759
|
110
|
120
|
|
Overall Study
NOT COMPLETED
|
88
|
86
|
101
|
93
|
Reasons for withdrawal
| Measure |
Nepafenac 0.3%
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
17
|
9
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient Decision Unrelated to Advrs Evnt
|
5
|
0
|
2
|
0
|
|
Overall Study
Noncompliance
|
0
|
1
|
0
|
0
|
|
Overall Study
Treatment Failure
|
25
|
32
|
69
|
64
|
|
Overall Study
Protocol Violation
|
4
|
5
|
1
|
2
|
|
Overall Study
Patient Did Not Use Study Medication
|
34
|
26
|
11
|
7
|
|
Overall Study
Not Specifiied
|
5
|
4
|
9
|
14
|
Baseline Characteristics
Confirmatory Study Nepafenac 0.3%
Baseline characteristics by cohort
| Measure |
Nepafenac 0.3%
n=807 Participants
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
n=813 Participants
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
n=197 Participants
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
n=205 Participants
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Total
n=2022 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
68.7 years
STANDARD_DEVIATION 9.08 • n=93 Participants
|
68.8 years
STANDARD_DEVIATION 9.31 • n=4 Participants
|
69.8 years
STANDARD_DEVIATION 9.31 • n=27 Participants
|
68.9 years
STANDARD_DEVIATION 9.37 • n=483 Participants
|
68.9 years
STANDARD_DEVIATION 9.22 • n=36 Participants
|
|
Sex: Female, Male
Female
|
465 Participants
n=93 Participants
|
458 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
115 Participants
n=483 Participants
|
1156 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
342 Participants
n=93 Participants
|
355 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
866 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.
Outcome measures
| Measure |
Nepafenac 0.3%
n=807 Participants
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
n=811 Participants
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
n=197 Participants
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
n=205 Participants
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
|---|---|---|---|---|
|
Percentage of Patients Cured at Day 14
|
68.4 percentage of participants
|
70.0 percentage of participants
|
34.0 percentage of participants
|
35.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day 14Population: All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.
Outcome measures
| Measure |
Nepafenac 0.3%
n=807 Participants
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
n=811 Participants
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
n=197 Participants
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
n=205 Participants
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
|---|---|---|---|---|
|
Percentage of Patients Pain-Free at Day 14
|
91 percentage of participants
|
90.9 percentage of participants
|
49.7 percentage of participants
|
56.1 percentage of participants
|
Adverse Events
Nepafenac 0.3%
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
NEVANAC
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Nepafenac Vehicle 0.3%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NEVANAC Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nepafenac 0.3%
n=817 participants at risk
Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC
n=819 participants at risk
Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
Nepafenac Vehicle 0.3%
n=200 participants at risk
Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
|
NEVANAC Vehicle
n=206 participants at risk
Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Nervous system disorders
Brain Oedema
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.12%
1/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Injury, poisoning and procedural complications
Injury
|
0.24%
2/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage IV
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Cardiac disorders
Myocardial Infarction
|
0.12%
1/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.12%
1/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
|
Infections and infestations
Sepsis
|
0.00%
0/817 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.12%
1/819 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/200 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
0.00%
0/206 • Adverse events were collected for the duration of the study.
This reporting group includes all patients who received exposure to the study medication or potential exposure to the study medication: 2042. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic disease/conditions since surgery were recorded.
|
Other adverse events
Adverse event data not reported
Additional Information
Dana Sager, Clinical Manager Group Leader
Alcon Research
Phone: 1-817-551-8603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER