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Trial record 9 of 25 for:    "Lens Disease" | "Nepafenac"

Nevanac 3-Month Safety Study With QID Dosing

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: NCT00332774
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE June 1, 2006
First Posted Date  ICMJE June 2, 2006
Last Update Posted Date March 5, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
Macular thickness
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00332774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nevanac 3-Month Safety Study With QID Dosing
Official Title  ICMJE A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
Brief Summary The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Drug: Nepafenac ophthalmic solution 0.1%
    1 drop 4 times daily for 90 days
  • Drug: Ketorolac Tromethamine ophthalmic solution 0.4%
    1 drop 4 times daily for 90 days
  • Other: Nepafenac ophthalmic suspension vehicle
    Other Name: 1 drop 4 times daily for 14 days after surgery
Study Arms  ICMJE
  • Experimental: Nevanac
    Intervention: Drug: Nepafenac ophthalmic solution 0.1%
  • Active Comparator: Acular
    Intervention: Drug: Ketorolac Tromethamine ophthalmic solution 0.4%
  • Placebo Comparator: Vehicle
    Intervention: Other: Nepafenac ophthalmic suspension vehicle
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: March 1, 2012)
149
Original Enrollment  ICMJE
 (submitted: June 1, 2006)
150
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 10
  • Other protocol-defined exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, 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 NCT00332774
Other Study ID Numbers  ICMJE C-05-20
Has Data Monitoring Committee Not Provided
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
Study Director: Stephen Lane Medical Monitor
PRS Account Alcon Research
Verification Date March 2012

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