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A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521456
First Posted: August 27, 2007
Last Update Posted: October 1, 2009
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:
Allergan
  Purpose
This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery

Condition Intervention Phase
Cataract Extraction Drug: ketorolac eye drops Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Resolution of Post Operative Inflammation [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Ocular Pain [ Time Frame: Day 1 ]
  • Mean Pupil Area [ Time Frame: Day 0 ]

Enrollment: 263
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ketorolac eye drops

1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day

Placebo

Placebo Comparator: 2 Drug: ketorolac eye drops

1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day

Placebo


  Eligibility

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 undergoing cataract surgery

Exclusion Criteria:

  • Uncontrolled ocular disease in cataract surgery eye
  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): NCT00521456


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00521456     History of Changes
Other Study ID Numbers: 191578-006
First Submitted: August 23, 2007
First Posted: August 27, 2007
Results First Submitted: August 19, 2009
Results First Posted: October 1, 2009
Last Update Posted: October 1, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ketorolac
Ketorolac Tromethamine
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