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OpenTrials
Completed

NCT Number: NCT00405730

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bordeaux

Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Under 18.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nepafenac 1mg/ml eye drops, suspension

Drug

One drop in the study eye 3 times daily for 23 days

Ketorolac Trometamol 5 mg/ml eye drops, solution

Drug

One drop in the study eye 3 times daily for 23 days

Nepafenac vehicle eye drops

Other

One drop in the study eye 3 times daily for 23 days

Primary outcomes

  1. Percentage of Patients with Day 14 Cure

    Time frame: Day 14

    Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 30, 2006
Registry last updated
Nov 18, 2016

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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