Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedAugust 13, 2012
August 1, 2012
1.2 years
May 19, 2009
August 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Aqueous flare
Post-operative day 1 & day 7
Secondary Outcomes (2)
Aqueous flare
Postoperative day 30 and day 90
Change from baseline of retinal thickness
Postoperative day 30 & day 90
Study Arms (2)
Indomethacin
EXPERIMENTALIndomethacin ophthalmic solution 0.1% for post-surgical inflammation
Ketorolac
ACTIVE COMPARATORKetorolac ophthalmic solution 0.5% for post-surgical inflammation
Interventions
Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb
Berlin, D 13581, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gabriele Brenger
Bausch & Lomb Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 20, 2009
Study Start
April 1, 2008
Primary Completion
June 1, 2009
Study Completion
September 1, 2009
Last Updated
August 13, 2012
Record last verified: 2012-08