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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:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405730

Locations
France
Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00405730     History of Changes
Other Study ID Numbers: C-04-65, 2005-002647-35
Study First Received: November 29, 2006
Last Updated: April 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Alcon Research:
Cataracts

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Tetrahydrozoline
Ketorolac
Ketorolac Tromethamine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013