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Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 20, 2009
Last Update Posted: August 13, 2012
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 (Responsible Party):
Bausch & Lomb Incorporated
This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.

Condition Intervention Phase
Cataract Inflammation Drug: Indomethacin ophthalmic solution Drug: Ketorolac Ophthalmic Solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Aqueous flare [ Time Frame: Post-operative day 1 & day 7 ]

Secondary Outcome Measures:
  • Aqueous flare [ Time Frame: Postoperative day 30 and day 90 ]
  • Change from baseline of retinal thickness [ Time Frame: Postoperative day 30 & day 90 ]

Enrollment: 120
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin
Indomethacin ophthalmic solution 0.1% for post-surgical inflammation
Drug: Indomethacin ophthalmic solution
Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
Active Comparator: Ketorolac
Ketorolac ophthalmic solution 0.5% for post-surgical inflammation
Drug: Ketorolac Ophthalmic Solution
Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery


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

Inclusion Criteria:

  • Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
  • Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.

Exclusion Criteria:

  • Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
  • Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study.
  • Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
  • Subjects with immunodepression.
  • Subjects with a history of intolerance to the study drug or to any NSAI drug.
  • Subjects who are monocular for any reason other than cataract.
  • Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.
  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): NCT00904904

Bausch & Lomb
Berlin, Germany, D 13581
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Gabriele Brenger Bausch & Lomb Incorporated
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00904904     History of Changes
Other Study ID Numbers: 539
2007-004686-18 ( EudraCT Number )
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: August 13, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents