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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00405730

First received: November 29, 2006

Last updated: April 3, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 29, 2006
Last Updated Date	April 3, 2012
Start Date ^ICMJE	November 2005
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 3, 2012)	Percentage of Patients with Day 14 Cure [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ] Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
Original Primary Outcome Measures ^ICMJE (submitted: November 29, 2006)	Percentage of patients with Day 14 cure (inflammation score = 0)
Change History	Complete list of historical versions of study NCT00405730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: November 29, 2006)	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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Cataracts
Intervention ^ICMJE	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
Study Arm (s)	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
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
Enrollment ^ICMJE	227
Completion Date	July 2006
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00405730
Other Study ID Numbers ^ICMJE	C-04-65, 2005-002647-35
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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