- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346528
Safety of NGOIS Compared to BSS Plus in Pediatric Patients
March 1, 2012 updated by: Alcon Research
To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
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
-
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon for Trial Locations
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-
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
1 week to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cataract present.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- As per age requirements.
- 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 |
---|
Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
|
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
July 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
June 28, 2006
First Submitted That Met QC Criteria
June 28, 2006
First Posted (Estimate)
June 30, 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-04-64
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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