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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
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 227
Study Start Date: November 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00405730     History of Changes
Other Study ID Numbers: C-04-65
2005-002647-35
First Submitted: November 29, 2006
First Posted: November 30, 2006
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