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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00521456
First received: August 23, 2007
Last updated: September 29, 2009
Last verified: August 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular Pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Mean Pupil Area [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing cataract surgery

Exclusion Criteria:

  • Uncontrolled ocular disease in cataract surgery eye
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521456

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

Additional Information:
No publications provided by Allergan

Additional 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
Study First Received: August 23, 2007
Results First Received: August 19, 2009
Last Updated: September 29, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014