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Nepafenac Compared to Placebo for Ocular Pain and Inflammation

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ClinicalTrials.gov Identifier: NCT01426854
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Drug: Nepafenac Ophthalmic Suspension, 0.1%
Other: Nepafenac Vehicle Ophthalmic Solution
Enrollment 260
Recruitment Details 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.
Pre-assignment Details This reporting group includes all enrolled participants.
Arm/Group Title Nepafenac Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 131 129
Completed 119 98
Not Completed 12 31
Reason Not Completed
Adverse Event             1             5
Subject Decision Unrelated to AE             5             6
Lost to Follow-up             3             0
Noncompliance             0             1
Treatment Failure             0             16
Protocol Deviation             0             1
Other             3             2
Arm/Group Title Nepafenac Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 125 123 248
Hide Baseline Analysis Population Description
Demographics are presented for the 248 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.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 123 participants 248 participants
68.8  (10.62) 69.8  (10.19) 69.3  (10.40)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 123 participants 248 participants
18 to <65 years 35 33 68
65 to <75 years 43 44 87
75 to <85 years 42 43 85
85 to <95 years 5 3 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 123 participants 248 participants
Female
72
  57.6%
72
  58.5%
144
  58.1%
Male
53
  42.4%
51
  41.5%
104
  41.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 125 participants 123 participants 248 participants
125 123 248
1.Primary Outcome
Title Proportion of Subjects With Clinical Cure at Day 14
Hide Description 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.
Time Frame Day 14 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.
Arm/Group Title Nepafenac Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 122
Measure Type: Number
Unit of Measure: Percentage of subjects
80.3 39.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nepafenac, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
Hide Description 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.
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.
Arm/Group Title Nepafenac Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 122 122
Measure Type: Number
Unit of Measure: Percentage of subjects
71.3 40.2
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Nepafenac Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Nepafenac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nepafenac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   1/123 (0.81%) 
Nervous system disorders     
Vascular headache  1 [1]  0/125 (0.00%)  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
Not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nepafenac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/123 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Terence Li, Clinical Research Manager, Development & Medical Affairs, China
Organization: Alcon (China) Ophthalmic Product Co., Ltd.
Phone: +86 10 5829 1452
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01426854     History of Changes
Other Study ID Numbers: C-10-026
First Submitted: August 30, 2011
First Posted: September 1, 2011
Results First Submitted: March 27, 2013
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013