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

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ClinicalTrials.gov Identifier: NCT00405730
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Cataracts Drug: Nepafenac 1mg/ml eye drops, suspension Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution Other: Nepafenac vehicle eye drops Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Nepafenac
One drop in the study eye 3 times daily for 23 days
 Drug: Nepafenac 1mg/ml eye drops, suspension
One drop in the study eye 3 times daily for 23 days
Active Comparator: Ketorolac Trometamol
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
Placebo Comparator: Nepafenac Vehicle
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405730


Locations
France
Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
Alcon Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00405730     History of Changes
Other Study ID Numbers: C-04-65
2005-002647-35
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: April 2012

Keywords provided by Alcon Research:
Cataracts

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Ketorolac
Ketorolac Tromethamine
Nepafenac
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action