CompletedInterventionalPhase 4Updated Jun 25, 2007
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery | NCT00904904 | Trialant
CompletedInterventionalPhase 4Updated Aug 13, 2012
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
ClinicalTrials.gov ID
NCT00904904
Lead Sponsor
Bausch & Lomb IncorporatedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
120Actual
Last Update Posted
Aug 13, 2012Estimated
Start Date
Apr 2008
Primary Completion Date
Jun 2009Actual
Completion Date
Sep 2009Actual
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.
Cataract
Inflammation
Indomethacin ophthalmic solution
Ketorolac Ophthalmic Solution
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.