A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00521456

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 III

MedlinePlus related topics: Cataract

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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 - 14 ] [ Designated as safety issue: No ]
Mean pupil area [ Time Frame: Day 1 ] [ 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
1: Experimental	Drug: ketorolac eye drops 1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo
2: Placebo Comparator	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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191578-006
Study First Received:	August 23, 2007
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00521456
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Cataract
Ketorolac
Lens Diseases

Pain
Tetrahydrozoline
Ketorolac Tromethamine
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009