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:
NCT00524264
First received: August 30, 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
Pain
Inflammation
Drug: ketorolac
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: 248
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ketorolac

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

Placebo Comparator: 2 Drug: ketorolac

Ophthalmic drops, BID pre- and post-operation, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524264

Locations
United States, California
Artesia, 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: NCT00524264     History of Changes
Other Study ID Numbers: 191578-005
Study First Received: August 30, 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
Inflammation
Eye Diseases
Lens Diseases
Pathologic Processes
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014