Trial Outcomes & Findings for Nepafenac Compared to Placebo for Ocular Pain and Inflammation (NCT NCT01426854)

Last Updated: 2013-05-13

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. The proportion of subjects with a clinical cure is reported as percentage.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

260 participants

Primary outcome timeframe

Day 14 postoperative

Results posted on

2013-05-13

Participant Flow

Participants were recruited from 8 study centers in China. Chinese men or women of at least 18 years of age who needed cataract extraction with implantation of a posterior chamber intraocular lens were enrolled and randomized in a ratio of 1:1 to receive either nepafenac or placebo.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Overall Study STARTED	131	129
Overall Study COMPLETED	119	98
Overall Study NOT COMPLETED	12	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Overall Study Adverse Event	1	5
Overall Study Subject Decision Unrelated to AE	5	6
Overall Study Lost to Follow-up	3	0
Overall Study Noncompliance	0	1
Overall Study Treatment Failure	0	16
Overall Study Protocol Deviation	0	1
Overall Study Other	3	2

Baseline Characteristics

Nepafenac Compared to Placebo for Ocular Pain and Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nepafenac n=125 Participants Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo n=123 Participants Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Total n=248 Participants Total of all reporting groups
Age Continuous	68.8 years STANDARD_DEVIATION 10.62 • n=5 Participants	69.8 years STANDARD_DEVIATION 10.19 • n=7 Participants	69.3 years STANDARD_DEVIATION 10.40 • n=5 Participants
Age, Customized 18 to <65 years	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants
Age, Customized 65 to <75 years	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Age, Customized 75 to <85 years	42 participants n=5 Participants	43 participants n=7 Participants	85 participants n=5 Participants
Age, Customized 85 to <95 years	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment China	125 participants n=5 Participants	123 participants n=7 Participants	248 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 postoperative

Population: Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.

Outcome measures

Outcome measures
Measure	Nepafenac n=122 Participants Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo n=122 Participants Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Proportion of Subjects With Clinical Cure at Day 14	80.3 Percentage of subjects	39.3 Percentage of subjects

SECONDARY outcome

Timeframe: Up to Day 14

Population: Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.

Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.

Outcome measures

Outcome measures
Measure	Nepafenac n=122 Participants Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo n=122 Participants Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Proportion of Subjects Who Were Pain-Free at All Postoperative Visits	71.3 Percentage of subjects	40.2 Percentage of subjects

Adverse Events

Nepafenac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nepafenac n=125 participants at risk Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.	Placebo n=123 participants at risk Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Nervous system disorders Vascular headache	0.00% 0/125 • Adverse events were collected for the duration of the study. Individual adverse events were recorded from the start of study treatment. At each visit, after the subject spontaneously mentioned any problems, the study staff inquired about adverse events. The safety population includes all participants who received at least one dose of study drug or discontinued before surgery and failed to return the test article bottle or returned the bottle with a broken seal.	0.81% 1/123 • Adverse events were collected for the duration of the study. Individual adverse events were recorded from the start of study treatment. At each visit, after the subject spontaneously mentioned any problems, the study staff inquired about adverse events. The safety population includes all participants who received at least one dose of study drug or discontinued before surgery and failed to return the test article bottle or returned the bottle with a broken seal.

Other adverse events

Adverse event data not reported

Additional Information

Terence Li, Clinical Research Manager, Development & Medical Affairs, China

Alcon (China) Ophthalmic Product Co., Ltd.

Phone: +86 10 5829 1452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results, materials of research, relevant intellectual property, and trial materials may not be used, disclosed, revealed, or published in any form without Sponsor's prior written consent.
Publication restrictions are in place

Restriction type: OTHER