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OpenTrials
Completed

NCT Number: NCT00904904

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

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.

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Key information

Conditions

Cataract Eye Diseases Inflammation Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bausch & Lomb

Berlin, D 13581, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indomethacin ophthalmic solution

Drug

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

Ketorolac Ophthalmic Solution

Drug

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

Primary outcomes

  1. Aqueous flare

    Time frame: Post-operative day 1 & day 7

Secondary outcomes

  1. Aqueous flare

    Time frame: Postoperative day 30 and day 90

  2. Change from baseline of retinal thickness

    Time frame: Postoperative day 30 & day 90

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 20, 2009
Registry last updated
Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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