DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
NCT ID: NCT00596583
Last Updated: 2009-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2007-04-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High Dose
DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
Low Dose
DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
Interventions
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DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
* Be aged at least 18 years old at the time of enrollment;
* Be able to tolerate a surgical procedure for up to 3 hours;
* Be in a medical condition suitable for cataract surgery;
* Able and willing to participate in study examinations and visit schedule; and
* Understand and freely consent to participate in the study.
Exclusion Criteria
* Known allergy to BBG 250;
* Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
* Active treatment for cancer or systemic infection within the past month;
* Active treatment with systemic corticosteroids within the past month;
* Previous participation in this Study for the contralateral eye;
* Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
* Unwillingness to participate in the study or inability to give informed consent; or
* Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.
18 Years
ALL
No
Sponsors
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Aqumen Biopharmaceuticals, N.A.
INDUSTRY
Responsible Party
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Aqumen Biopharmaceuticals, N.A.
Principal Investigators
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Hardy Kagimoto, M.D.
Role: STUDY_DIRECTOR
Aqumen Biopharmaceuticals, N.A.
Locations
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McDonald Eye Associates
Fayetteville, Arkansas, United States
Peace Laser Eye Center
Inglewood, California, United States
Capitol City Surgery Center
Sacramento, California, United States
The Eye Institute of West Florida
Largo, Florida, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
St. John's Clinic Eye Specialists
Springfield, Missouri, United States
Ballas Surgery Center
St Louis, Missouri, United States
Wills Eye Surgery Center
Cherry Hill, New Jersey, United States
Brar-Parekh Eye Associates
Woodland Park, New Jersey, United States
Island Eye Surgicenter
Carle Place, New York, United States
The Ohio State University Hospital
Columbus, Ohio, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Wills Eye Surgery Center
Philadelphia, Pennsylvania, United States
Wills Surgery Center
Philadelphia, Pennsylvania, United States
SMDV Surgery Center
Madison, Wisconsin, United States
Narayana Nethralaya
Bangalore, Karnataka, India
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, India
Narayana Nethralaya
Bangalore, Karnataka, India
The Mehta International Eye Institute & Colaba Eye Hospital
Mumbai, Maharashtra, India
Bombay City Eye Institute & Research Centre
Mumbai, Maharashtra, India
Countries
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Other Identifiers
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US IND 75,735
Identifier Type: -
Identifier Source: secondary_id
AQNA-DY001
Identifier Type: -
Identifier Source: org_study_id
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