Back to resultsNepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Nepafenac 1mg/ml eye drops, suspension
Ketorolac Trometamol 5 mg/ml eye drops, solution
Nepafenac vehicle eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataracts
Eligibility Criteria
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.
Sites / Locations
- Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Nepafenac
Ketorolac Trometamol
Nepafenac Vehicle
Arm Description
One drop in the study eye 3 times daily for 23 days
One drop in the study eye 3 times daily for 23 days
One drop in the study eye 3 times daily for 23 days
Outcomes
Primary Outcome Measures
Percentage of Patients with Day 14 Cure
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00405730
Brief Title
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nepafenac
Arm Type
Experimental
Arm Description
One drop in the study eye 3 times daily for 23 days
Arm Title
Ketorolac Trometamol
Arm Type
Active Comparator
Arm Description
One drop in the study eye 3 times daily for 23 days
Arm Title
Nepafenac Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop in the study eye 3 times daily for 23 days
Intervention Type
Drug
Intervention Name(s)
Nepafenac 1mg/ml eye drops, suspension
Intervention Description
One drop in the study eye 3 times daily for 23 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac Trometamol 5 mg/ml eye drops, solution
Intervention Description
One drop in the study eye 3 times daily for 23 days
Intervention Type
Other
Intervention Name(s)
Nepafenac vehicle eye drops
Intervention Description
One drop in the study eye 3 times daily for 23 days
Primary Outcome Measure Information:
Title
Percentage of Patients with Day 14 Cure
Description
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19668532
Citation
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.
Results Reference
result
Learn more about this trial
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
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