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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00333268
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS) Drug: BSS Plus Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2004
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
Drug Information available for: BSS plus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: NGOIS Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
Volume sufficient to irrigate adequately during cataract surgery
Active Comparator: BSS Plus Drug: BSS Plus
Volume sufficient to irrigate adequately during cataract surgery


Outcome Measures

Primary Outcome Measures :
  1. Percent change in endothelial cell density

Secondary Outcome Measures :
  1. Best corrected logMAR visual acuity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333268


Locations
United States, Texas
United States
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333268     History of Changes
Other Study ID Numbers: C-04-14
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions