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

March 1, 2012 updated by: Alcon Research

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

369

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Fort Worth, Texas, United States, 76134
        • United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGOIS
Volume sufficient to irrigate adequately during cataract surgery
Active Comparator: BSS Plus
Volume sufficient to irrigate adequately during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in endothelial cell density

Secondary Outcome Measures

Outcome Measure
Best corrected logMAR visual acuity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Next Generation Ophthalmic Irrigating Solution (NGOIS)

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