Back to resultsSafety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Next Generation Ophthalmic Irrigating Solution (NGOIS)
BSS Plus
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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.
Sites / Locations
- United States
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NGOIS
BSS Plus
Arm Description
Outcomes
Primary Outcome Measures
Percent change in endothelial cell density
Secondary Outcome Measures
Best corrected logMAR visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333268
Brief Title
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
369 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGOIS
Arm Type
Experimental
Arm Title
BSS Plus
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Next Generation Ophthalmic Irrigating Solution (NGOIS)
Intervention Description
Volume sufficient to irrigate adequately during cataract surgery
Intervention Type
Drug
Intervention Name(s)
BSS Plus
Intervention Description
Volume sufficient to irrigate adequately during cataract surgery
Primary Outcome Measure Information:
Title
Percent change in endothelial cell density
Secondary Outcome Measure Information:
Title
Best corrected logMAR visual acuity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
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