- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00333268
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
Status
Completed
Conditions
Intervention / Treatment
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.
Clinical Trials on Cataract
-
Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
-
Johannes Kepler University of LinzCompletedCataract Complicated | Cataract Complications OperationsAustria
-
Gemini Eye ClinicRecruitingBilateral Cataract | Unilateral CataractCzechia
-
Universitaire Ziekenhuizen KU LeuvenLaboratoires TheaRecruiting
-
Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
-
Yonsei UniversityCompletedCataract PatientsKorea, Republic of
-
Johannes Kepler University of LinzRecruitingAphakia | Secondary Cataract Surgery | Complicated Cataract SurgeryAustria
-
Advanced Center for Eyecare GlobalNot yet recruiting
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingCataract ExtractionChina
Clinical Trials on Next Generation Ophthalmic Irrigating Solution (NGOIS)
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted
-
University of MonastirLoussaief Chawki; Nissaf Ben Alaya; Cyrine Ben Nasrallah; Manel Ben Belgacem; Hela... and other collaboratorsCompleted
-
University of FloridaNational Institute of Allergy and Infectious Diseases (NIAID)Recruiting
-
Yael P MosseNovartis Pharmaceuticals; Foundation MedicineTerminated
-
University of WashingtonUnknownSubstance-Related DisordersUnited States