Back to resultsNext Generation Ophthalmic Irrigating Solution Posterior Segment Study
Primary Purpose
Eye Diseases
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 Eye Diseases focused on measuring epimacular membrane
Eligibility Criteria
Inclusion Criteria: Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18 years of age. 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
Best-corrected logMAR visual acuity
Secondary Outcome Measures
Intraocular pressure (IOP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333203
Brief Title
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
Official Title
Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
epimacular membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
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
Other
Intervention Name(s)
BSS Plus
Intervention Description
Volume sufficient to irrigate adequately during cataract surgery
Primary Outcome Measure Information:
Title
Best-corrected logMAR visual acuity
Secondary Outcome Measure Information:
Title
Intraocular pressure (IOP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Under 18 years of age.
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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Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
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