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OpenTrials
Completed

NCT Number: NCT00332774

Nevanac 3-Month Safety Study With QID Dosing

The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Under 10
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Nepafenac ophthalmic solution 0.1%

Drug

1 drop 4 times daily for 90 days

Ketorolac Tromethamine ophthalmic solution 0.4%

Drug

1 drop 4 times daily for 90 days

Nepafenac ophthalmic suspension vehicle

Other

Other names: 1 drop 4 times daily for 14 days after surgery

Primary outcomes

  1. Macular thickness

Secondary outcomes

  1. contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 2, 2006
Registry last updated
Mar 5, 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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