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Nevanac 3-Month Safety Study With QID Dosing

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.
ClinicalTrials.gov Identifier: NCT00332774
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Condition or disease Intervention/treatment Phase
Cataract Drug: Nepafenac ophthalmic solution 0.1% Drug: Ketorolac Tromethamine ophthalmic solution 0.4% Other: Nepafenac ophthalmic suspension vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
Study Start Date : February 2006
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nevanac Drug: Nepafenac ophthalmic solution 0.1%
1 drop 4 times daily for 90 days
Active Comparator: Acular Drug: Ketorolac Tromethamine ophthalmic solution 0.4%
1 drop 4 times daily for 90 days
Placebo Comparator: Vehicle Other: Nepafenac ophthalmic suspension vehicle
Other Name: 1 drop 4 times daily for 14 days after surgery



Primary Outcome Measures :
  1. Macular thickness

Secondary Outcome Measures :
  1. contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 10
  • Other protocol-defined exclusion criteria may apply

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): NCT00332774


Locations
United States, Texas
Contact Alcon for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Stephen Lane Medical Monitor

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00332774     History of Changes
Other Study ID Numbers: C-05-20
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

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