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

Inflammation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904904
• Other study ID #: 539
• Secondary ID: 2007-004686-18
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2009
• Last updated: August 10, 2012
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Indomethacin ophthalmic solution
Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
• Ketorolac Ophthalmic Solution
Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery

Locations

Country	Name	City	State
Germany	Bausch & Lomb	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aqueous flare		Post-operative day 1 & day 7	No
Secondary	Aqueous flare		Postoperative day 30 and day 90	No
Secondary	Change from baseline of retinal thickness		Postoperative day 30 & day 90	No