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

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: NCT00521456
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Extraction Drug: ketorolac eye drops Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
Drug Information available for: Ketorolac
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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



Outcome Measures

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

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

Eligibility Criteria

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 Posted: August 27, 2007    Key Record Dates
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