DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

Completed · Phase 3

Conditions studied: Mature Cataracts

In brief

The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.

Key facts

Study ID

NCT00596583

Run by

Aqumen Biopharmaceuticals, N.A.

People needed

300

Starts

2007-04-01

Expected to finish

2008-05-01

Last updated by the study team

2009-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
• 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.

You may not qualify if…

• In either eye, ocular infection or inflammation within the past 3 months;
• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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