Back to resultsIndomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Primary Purpose
Cataract, Inflammation
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Indomethacin ophthalmic solution
Ketorolac Ophthalmic Solution
Sponsored by
About this trial
This is an interventional prevention trial for Cataract
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.
Sites / Locations
- Bausch & Lomb
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Indomethacin
Ketorolac
Arm Description
Indomethacin ophthalmic solution 0.1% for post-surgical inflammation
Ketorolac ophthalmic solution 0.5% for post-surgical inflammation
Outcomes
Primary Outcome Measures
Aqueous flare
Secondary Outcome Measures
Aqueous flare
Change from baseline of retinal thickness
Full Information
NCT ID
NCT00904904
First Posted
May 19, 2009
Last Updated
August 10, 2012
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00904904
Brief Title
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indomethacin
Arm Type
Experimental
Arm Description
Indomethacin ophthalmic solution 0.1% for post-surgical inflammation
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac ophthalmic solution 0.5% for post-surgical inflammation
Intervention Type
Drug
Intervention Name(s)
Indomethacin ophthalmic solution
Intervention Description
Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
Intervention Type
Drug
Intervention Name(s)
Ketorolac Ophthalmic Solution
Intervention Description
Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery
Primary Outcome Measure Information:
Title
Aqueous flare
Time Frame
Post-operative day 1 & day 7
Secondary Outcome Measure Information:
Title
Aqueous flare
Time Frame
Postoperative day 30 and day 90
Title
Change from baseline of retinal thickness
Time Frame
Postoperative day 30 & day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Brenger
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Berlin
ZIP/Postal Code
D 13581
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
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