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

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ClinicalTrials.gov Identifier: NCT00904904
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : August 13, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Inflammation Drug: Indomethacin ophthalmic solution Drug: Ketorolac Ophthalmic Solution Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Study Start Date : April 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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:

  • 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.

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


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

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

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Ketorolac
Ketorolac Tromethamine
Indomethacin
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
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents