Trial Outcomes & Findings for Nepafenac 0.3% Two Study (NCT NCT01318499)

Last Updated: 2012-12-17

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 aqueous cells and aqueous flare.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1342 participants

Primary outcome timeframe

Day 14 postoperative

Results posted on

2012-12-17

Participant Flow

Patients were randomized from 37 investigational sites in the US.

Of the 1342 enrolled patients, 60 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least one postoperative assessment (intent-to-treat): 1257

Participant milestones

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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac 0.1% Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Overall Study STARTED	540	534	268
Overall Study COMPLETED	475	458	121
Overall Study NOT COMPLETED	65	76	147

Reasons for withdrawal

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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac 0.1% Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Overall Study Adverse Event	16	11	6
Overall Study Pt Decision Unrelated to Adverse Event	1	1	2
Overall Study Noncompliance	2	3	0
Overall Study Treatment Failure	19	19	101
Overall Study Protocol Violation	2	4	2
Overall Study Patient Did Not Use Study Medication	18	28	14
Overall Study Other	7	10	22

Baseline Characteristics

Nepafenac 0.3% Two Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac 0.1% n=493 Participants Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=252 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Total n=1257 Participants Total of all reporting groups
Age Continuous	69.3 years STANDARD_DEVIATION 9.26 • n=5 Participants	69.4 years STANDARD_DEVIATION 9.15 • n=7 Participants	69.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	69.3 years STANDARD_DEVIATION 9.28 • n=4 Participants
Sex: Female, Male Female	282 Participants n=5 Participants	301 Participants n=7 Participants	142 Participants n=5 Participants	725 Participants n=4 Participants
Sex: Female, Male Male	230 Participants n=5 Participants	192 Participants n=7 Participants	110 Participants n=5 Participants	532 Participants n=4 Participants
Region of Enrollment United States	512 participants n=5 Participants	493 participants n=7 Participants	252 participants n=5 Participants	1257 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 14 postoperative

Population: All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.

Outcome measures

Outcome measures
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=252 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%	64.6 Percentage of patients	25.0 Percentage of patients	—

SECONDARY outcome

Timeframe: Day 7 postoperative

Population: All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.

Outcome measures

Outcome measures
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=493 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%	31.3 Percentage of patients	30.8 Percentage of patients	—

POST_HOC outcome

Timeframe: Day 1, Day 3, Day 7, Day 14

Population: All randomized patients with at least one post-operative assessment (intent-to-treat).

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). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits.

Outcome measures

Outcome measures
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=493 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=252 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Cumulative Percent Clinical Success by Visit Day 1	18.9 Percentage of patients	15.0 Percentage of patients	12.3 Percentage of patients
Cumulative Percent Clinical Success by Visit Day 3	43.9 Percentage of patients	35.9 Percentage of patients	18.7 Percentage of patients
Cumulative Percent Clinical Success by Visit Day 7	71.9 Percentage of patients	62.5 Percentage of patients	29.4 Percentage of patients
Cumulative Percent Clinical Success by Visit Day 14	84.8 Percentage of patients	81.3 Percentage of patients	37.7 Percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 3, Day 7, Day 14

Population: All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.

Outcome measures

Outcome measures
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=493 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=252 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Cumulative Percentage of Patients Cured by Visit Day 1	0.4 Percentage of patients	1.8 Percentage of patients	0.4 Percentage of patients
Cumulative Percentage of Patients Cured by Visit Day 3	6.4 Percentage of patients	7.1 Percentage of patients	3.2 Percentage of patients
Cumulative Percentage of Patients Cured by Visit Day 7	31.3 Percentage of patients	30.8 Percentage of patients	10.3 Percentage of patients
Cumulative Percentage of Patients Cured by Visit Day 14	64.6 Percentage of patients	65.3 Percentage of patients	25.0 Percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 3, Day 7, Day 14

Population: All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.

Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.

Outcome measures

Outcome measures
Measure	Nepafenac 0.3% n=512 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=493 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=252 Participants Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Cumulative Percentage of Patients Pain Free by Visit Day 1	65.2 Percentage of patients	61.9 Percentage of patients	17.5 Percentage of patients
Cumulative Percentage of Patients Pain Free by Visit Day 3	77.3 Percentage of patients	75.9 Percentage of patients	25.8 Percentage of patients
Cumulative Percentage of Patients Pain Free by Visit Day 7	84.8 Percentage of patients	83.0 Percentage of patients	31.7 Percentage of patients
Cumulative Percentage of Patients Pain Free by Visit Day 14	89.1 Percentage of patients	89.0 Percentage of patients	40.1 Percentage of patients

Adverse Events

Nepafenac 0.3%

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Nepafenac 0.1%

Serious events: 4 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

Serious adverse events

Serious adverse events
Measure	Nepafenac 0.3% n=522 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac 0.1% n=506 participants at risk Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery.	Nepafenac Vehicle 0.3% n=254 participants at risk Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.
Eye disorders Angle closure glaucoma	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Cardiac disorders Cardiac failure congestive	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Injury, poisoning and procedural complications Corneal abrasion	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Infections and infestations Endophthalmitis	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Infections and infestations Hypopyon	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Eye disorders Lens dislocation	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Eye disorders Retinal detachment	0.19% 1/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Infections and infestations Gastritis viral	0.00% 0/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.20% 1/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.20% 1/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Injury, poisoning and procedural complications Injury	0.00% 0/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.20% 1/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.
Eye disorders Visual acuity reduced	0.00% 0/522 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.20% 1/506 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/conditions since surgery were recorded.	0.00% 0/254 • Adverse events were collected for the duration of the study. The safety population includes all patients who received study medication, or potentially received study medication: 1282. At each study visit, the patient received an ocular exam, and any changes in ocular and systemic medications and/or systemic diseases/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