Status:
COMPLETED
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00904904
Start Date
April 1 2008
End Date
September 1 2009
Last Update
August 13 2012
Active Locations (1)
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1
Bausch & Lomb
Berlin, Germany, D 13581