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Trial record 3 of 25 for:    "Lens Disease" | "Nepafenac"

Confirmatory Study Nepafenac 0.3%

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ClinicalTrials.gov Identifier: NCT01109173
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : November 30, 2012
Last Update Posted : November 30, 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 Ophthalmic Suspension 0.3% Vehicle
Other: NEVANAC Vehicle
Enrollment 2120
Recruitment Details Patients were randomized from 65 sites in 5 countries: US (49), Hungary (6), Italy (4), Sweden (4), and Switzerland (2).
Pre-assignment Details 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.
Arm/Group Title Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC 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 dose was administered between 30-120 minutes prior to surgery. 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 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. 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.
Period Title: Overall Study
Started 851 845 211 213
Completed 763 759 110 120
Not Completed 88 86 101 93
Reason Not Completed
Adverse Event             15             17             9             6
Lost to Follow-up             0             1             0             0
Patient Decision Unrelated to Advrs Evnt             5             0             2             0
Noncompliance             0             1             0             0
Treatment Failure             25             32             69             64
Protocol Violation             4             5             1             2
Patient Did Not Use Study Medication             34             26             11             7
Not Specifiied             5             4             9             14
Arm/Group Title Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC Vehicle 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 dose was administered between 30-120 minutes prior to surgery. 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 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. 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 of all reporting groups
Overall Number of Baseline Participants 807 813 197 205 2022
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 807 participants 813 participants 197 participants 205 participants 2022 participants
68.7  (9.08) 68.8  (9.31) 69.8  (9.31) 68.9  (9.37) 68.9  (9.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 807 participants 813 participants 197 participants 205 participants 2022 participants
Female
465
  57.6%
458
  56.3%
118
  59.9%
115
  56.1%
1156
  57.2%
Male
342
  42.4%
355
  43.7%
79
  40.1%
90
  43.9%
866
  42.8%
1.Primary Outcome
Title Percentage of Patients Cured 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 cells and flare.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
Arm/Group Title Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC 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 dose was administered between 30-120 minutes prior to surgery.
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 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.
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 Number of Participants Analyzed 807 811 197 205
Measure Type: Number
Unit of Measure: percentage of participants
68.4 70.0 34.0 35.6
2.Secondary Outcome
Title Percentage of Patients Pain-Free at Day 14
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.
Arm/Group Title Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC 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 dose was administered between 30-120 minutes prior to surgery.
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 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.
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 Number of Participants Analyzed 807 811 197 205
Measure Type: Number
Unit of Measure: percentage of participants
91 90.9 49.7 56.1
Time Frame Adverse events were collected for the duration of the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC 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 dose was administered between 30-120 minutes prior to surgery. 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 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. 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.
All-Cause Mortality
Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nepafenac 0.3% NEVANAC Nepafenac Vehicle 0.3% NEVANAC Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/817 (0.86%)   3/819 (0.37%)   0/200 (0.00%)   0/206 (0.00%) 
Cardiac disorders         
Myocardial Infarction  1 [1]  1/817 (0.12%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Atrial Fibrillation  1 [1]  0/817 (0.00%)  1/819 (0.12%)  0/200 (0.00%)  0/206 (0.00%) 
Infections and infestations         
Appendicitis  1 [1]  1/817 (0.12%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Sepsis  1 [1]  0/817 (0.00%)  1/819 (0.12%)  0/200 (0.00%)  0/206 (0.00%) 
Injury, poisoning and procedural complications         
Injury  1 [1]  2/817 (0.24%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1 [1]  1/817 (0.12%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung Carcinoma Cell Type Unspecified Stage IV  1 [1]  1/817 (0.12%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Nervous system disorders         
Brain Oedema  1 [1]  1/817 (0.12%)  0/819 (0.00%)  0/200 (0.00%)  0/206 (0.00%) 
Cerebrovascular Accident  1 [1]  1/817 (0.12%)  1/819 (0.12%)  0/200 (0.00%)  0/206 (0.00%) 
Indicates events were collected by systematic assessment
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% NEVANAC Nepafenac Vehicle 0.3% NEVANAC Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/817 (0.00%)   0/819 (0.00%)   0/200 (0.00%)   0/206 (0.00%) 
This study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (eg, diabetic retinopathy), or 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
Layout table for Results Point of Contact information
Name/Title: Dana Sager, Clinical Manager Group Leader
Organization: Alcon Research
Phone: 1-817-551-8603
EMail: dana.sager@alconlabs.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01109173     History of Changes
Other Study ID Numbers: C-09-055
First Submitted: April 21, 2010
First Posted: April 23, 2010
Results First Submitted: November 1, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012