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Nepafenac 0.3% Two Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2011
First Posted Date  ICMJE March 18, 2011
Results First Submitted Date  ICMJE November 1, 2012
Results First Posted Date  ICMJE December 17, 2012
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2012)		 Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% [ Time Frame: Day 14 postoperative ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2011)		 Inflammatory cells and flare [ Time Frame: 2 weeks post dose administration ]
Inflammatory cells will be measured using aqueous cells score of 1: 1-5 cells; 2: 6-15 cells; 3: 16-30 cells; 4: > 30 cells Flare will be measured using aqueous flare score: 0: None; 1:Mild; 2: Moderate; 3:Severe
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2012)		 Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% [ Time Frame: Day 7 postoperative ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2011)		 Presence of Inflammatory cells at one week post dose administration [ Time Frame: 1 week ]
Inflammatory cells will be measured using aqueous cells score of
  1. 1-5 cells
  2. . 6-15 cells
  3. 16-30 cells
  4. > 30 cells
Current Other Pre-specified Outcome Measures
 (submitted: December 14, 2012)
  • Cumulative Percentage of Patients Cured by Visit [ Time Frame: Day 1, Day 3, Day 7, Day 14 ]
    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.
  • Cumulative Percentage of Patients Pain Free by Visit [ Time Frame: Day 1, Day 3, Day 7, Day 14 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nepafenac 0.3% Two Study
Official Title  ICMJE Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
Brief Summary The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Drug: Nepafenac Ophthalmic Suspension, 0.3%
    Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
  • Drug: Nepafenac Ophthalmic Suspension, 0.1%
    Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
    Other Name: NEVANAC®
  • Other: Nepafenac Vehicle 0.3%
    Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Nepafenac Ophthalmic Suspension, 0.3%
  • Active Comparator: 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.
    Intervention: Drug: Nepafenac Ophthalmic Suspension, 0.1%
  • Placebo Comparator: 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.
    Intervention: Other: Nepafenac Vehicle 0.3%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2011)		 1342
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2011)		 1250
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
  • Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
  • Able to understand and sign an informed consent;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
  • Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
  • History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
  • Diabetic retinopathy in the operative eye;
  • Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01318499
Other Study ID Numbers  ICMJE C-11-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP