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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00904904
First received: May 19, 2009
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aqueous flare [ Time Frame: Postoperative day 30 and day 90 ] [ Designated as safety issue: No ]
  • Change from baseline of retinal thickness [ Time Frame: Postoperative day 30 & day 90 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00904904

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00904904     History of Changes
Other Study ID Numbers: 539, 2007-004686-18
Study First Received: May 19, 2009
Last Updated: August 10, 2012
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Indomethacin
Ketorolac
Ketorolac Tromethamine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014