A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.

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Key information

Conditions

Cataract Extraction Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Artesia, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients undergoing cataract surgery

Exclusion criteria

Uncontrolled ocular disease in cataract surgery eye

Treatment and study plan

Ketorolac

Drug

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

Primary outcomes

Resolution of Post Operative Inflammation

Time frame: Day 14

Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)

Secondary outcomes

Ocular Pain

Time frame: Day 1

Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Mean Pupil Area

Time frame: Day 0

Pupil area post-irrigation and aspiration

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 3, 2007
Registry last updated: Oct 1, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed