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Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405730
First Posted: November 30, 2006
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Alcon Research
November 29, 2006
November 30, 2006
November 18, 2016
November 2005
July 2006   (Final data collection date for primary outcome measure)
Percentage of Patients with Day 14 Cure [ Time Frame: Day 14 ]
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
Percentage of patients with Day 14 cure (inflammation score = 0)
Complete list of historical versions of study NCT00405730 on ClinicalTrials.gov Archive Site
Not Provided
Mean aqueous cells and flare scores, percentage of treatment failures and of patients with clinically significant inflammation, and assessment of ocular pain, at each visit
Not Provided
Not Provided
 
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Cataracts
  • Drug: Nepafenac 1mg/ml eye drops, suspension
    One drop in the study eye 3 times daily for 23 days
  • Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution
    One drop in the study eye 3 times daily for 23 days
  • Other: Nepafenac vehicle eye drops
    One drop in the study eye 3 times daily for 23 days
  • Experimental: Nepafenac
    One drop in the study eye 3 times daily for 23 days
    Intervention: Drug: Nepafenac 1mg/ml eye drops, suspension
  • Active Comparator: Ketorolac Trometamol
    One drop in the study eye 3 times daily for 23 days
    Intervention: Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution
  • Placebo Comparator: Nepafenac Vehicle
    One drop in the study eye 3 times daily for 23 days
    Intervention: Other: Nepafenac vehicle eye drops
Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
July 2006
July 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 18.
  • Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00405730
C-04-65
2005-002647-35
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
April 2012

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