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OpenTrials
Completed

NCT Number: NCT00333918

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

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Key information

Conditions

Pain Inflammation Neurologic Manifestations 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

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
  • Agree to return for all required visits
  • Agree to avoid disallowed medications

Exclusion criteria

  • Known hypersensitivity to bromfenac and salicylates

Treatment and study plan

bromfenac ophthalmic solution

Drug

placebo comparator

Drug

Primary outcomes

  1. Reduction of ocular inflammation

Secondary outcomes

  1. Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 6, 2006
Registry last updated
Feb 15, 2013

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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