Nevanac 3-Month Safety Study With QID Dosing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00332774
First received: June 1, 2006
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Macular thickness

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

Enrollment: 149
Study Start Date: February 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00332774     History of Changes
Other Study ID Numbers: C-05-20
Study First Received: June 1, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014