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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00904904

Enrollment

120

Registered

2009-05-20

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2012-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Inflammation

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.

Interventions

DRUGIndomethacin ophthalmic solution

Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery

DRUGKetorolac Ophthalmic Solution

Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Aqueous flare	Post-operative day 1 & day 7

Secondary

Measure	Time frame
Aqueous flare	Postoperative day 30 and day 90
Change from baseline of retinal thickness	Postoperative day 30 & day 90

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026