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OpenTrials
Completed

NCT Number: NCT00333268

Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus

The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

United States

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 any race or sex 18 or older and undergoing 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

Next Generation Ophthalmic Irrigating Solution (NGOIS)

Drug

Volume sufficient to irrigate adequately during cataract surgery

BSS Plus

Drug

Volume sufficient to irrigate adequately during cataract surgery

Primary outcomes

  1. Percent change in endothelial cell density

Secondary outcomes

  1. Best corrected logMAR visual acuity

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
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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