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Nepafenac 0.3% Two Study

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ClinicalTrials.gov Identifier: NCT01318499
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Drug: Nepafenac Ophthalmic Suspension, 0.3%
Drug: Nepafenac Ophthalmic Suspension, 0.1%
Other: Nepafenac Vehicle 0.3%
Enrollment 1342
Recruitment Details Patients were randomized from 37 investigational sites in the US.
Pre-assignment Details 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
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Hide Arm/Group Description 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 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%, 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.
Period Title: Overall Study
Started 540 534 268
Completed 475 458 121
Not Completed 65 76 147
Reason Not Completed
Adverse Event             16             11             6
Pt Decision Unrelated to Adverse Event             1             1             2
Noncompliance             2             3             0
Treatment Failure             19             19             101
Protocol Violation             2             4             2
Patient Did Not Use Study Medication             18             28             14
Not Specified             7             10             22
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3% Total
Hide Arm/Group Description 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 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%, 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 of all reporting groups
Overall Number of Baseline Participants 512 493 252 1257
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 512 participants 493 participants 252 participants 1257 participants
69.3  (9.26) 69.4  (9.15) 69.3  (9.6) 69.3  (9.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 493 participants 252 participants 1257 participants
Female
282
  55.1%
301
  61.1%
142
  56.3%
725
  57.7%
Male
230
  44.9%
192
  38.9%
110
  43.7%
532
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 512 participants 493 participants 252 participants 1257 participants
512 493 252 1257
1.Primary Outcome
Title Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
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.
Time Frame Day 14 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.
Arm/Group Title Nepafenac 0.3% Nepafenac Vehicle 0.3%
Hide Arm/Group Description:
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%, 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 Number of Participants Analyzed 512 252
Measure Type: Number
Unit of Measure: Percentage of patients
64.6 25.0
2.Secondary Outcome
Title Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
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.
Time Frame Day 7 postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1%
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 512 493
Measure Type: Number
Unit of Measure: Percentage of patients
31.3 30.8
3.Other Pre-specified Outcome
Title Cumulative Percentage of Patients Cured by Visit
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. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.
Time Frame Day 1, Day 3, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac 0.3% Vehicle
Hide Arm/Group Description:
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 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%, 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 Number of Participants Analyzed 512 493 252
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1 0.4 1.8 0.4
Day 3 6.4 7.1 3.2
Day 7 31.3 30.8 10.3
Day 14 64.6 65.3 25.0
4.Other Pre-specified Outcome
Title Cumulative Percentage of Patients Pain Free by Visit
Hide Description 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.
Time Frame Day 1, Day 3, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac 0.3% Vehicle
Hide Arm/Group Description:
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 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%, 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 Number of Participants Analyzed 512 493 252
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1 65.2 61.9 17.5
Day 3 77.3 75.9 25.8
Day 7 84.8 83.0 31.7
Day 14 89.1 89.0 40.1
5.Post-Hoc Outcome
Title Cumulative Percent Clinical Success by Visit
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). 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.
Time Frame Day 1, Day 3, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one post-operative assessment (intent-to-treat).
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Hide Arm/Group Description:
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 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%, 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 Number of Participants Analyzed 512 493 252
Measure Type: Number
Unit of Measure: Percentage of patients
Day 1 18.9 15.0 12.3
Day 3 43.9 35.9 18.7
Day 7 71.9 62.5 29.4
Day 14 84.8 81.3 37.7
Time Frame Adverse events were collected for the duration of the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Hide Arm/Group Description 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 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%, 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.
All-Cause Mortality
Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nepafenac 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/522 (0.96%)   4/506 (0.79%)   0/254 (0.00%) 
Cardiac disorders       
Cardiac failure congestive 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Eye disorders       
Angle closure glaucoma 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Lens dislocation 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Retinal detachment 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Visual acuity reduced 1 [1]  0/522 (0.00%)  1/506 (0.20%)  0/254 (0.00%) 
Infections and infestations       
Endophthalmitis 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Hypopyon 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Gastritis viral 1 [1]  0/522 (0.00%)  1/506 (0.20%)  0/254 (0.00%) 
Injury, poisoning and procedural complications       
Corneal abrasion 1 [1]  1/522 (0.19%)  0/506 (0.00%)  0/254 (0.00%) 
Injury 1 [1]  0/522 (0.00%)  1/506 (0.20%)  0/254 (0.00%) 
Nervous system disorders       
Hypertensive encephalopathy 1 [1]  0/522 (0.00%)  1/506 (0.20%)  0/254 (0.00%) 
1
Term from vocabulary, MedDRA 13.0
[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 0.3% Nepafenac 0.1% Nepafenac Vehicle 0.3%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/522 (0.00%)   0/506 (0.00%)   0/254 (0.00%) 
Study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (diabetic retinopathy), and women of childbearing potential. Therefore, results may not be generalizable to these populations.
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Dana Sager, Clinical Manager Group Leader
Organization: Alcon Research
Phone: 1-817-551-8603
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01318499     History of Changes
Other Study ID Numbers: C-11-003
First Submitted: March 15, 2011
First Posted: March 18, 2011
Results First Submitted: November 1, 2012
Results First Posted: December 17, 2012
Last Update Posted: December 17, 2012