DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
- Conditions
- Mature Cataracts
- Interventions
- Drug: DYME
- Registration Number
- NCT00596583
- Lead Sponsor
- Aqumen Biopharmaceuticals, N.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose DYME - Low Dose DYME -
- Primary Outcome Measures
Name Time Method Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed. During surgery Uncomplicated discharge one week post-op
- Secondary Outcome Measures
Name Time Method Quality of stain during surgery Intra-ocular safety of DYME as measured by best corrected visual acuity, corneal endothelial cell count, intraocular pressure, presence/absence of retained dye, duration of surgery, and the absence of dye related adverse events 1-day and 1-week post-op
Trial Locations
- Locations (20)
Wills Eye Surgery Center
🇺🇸Philadelphia, Pennsylvania, United States
Bombay City Eye Institute & Research Centre
🇮🇳Mumbai, Maharashtra, India
Eye Surgeons of Indiana
🇺🇸Indianapolis, Indiana, United States
Center for Excellence in Eye Care
🇺🇸Miami, Florida, United States
Capitol City Surgery Center
🇺🇸Sacramento, California, United States
Peace Laser Eye Center
🇺🇸Inglewood, California, United States
Brar-Parekh Eye Associates
🇺🇸West Paterson, New Jersey, United States
SMDV Surgery Center
🇺🇸Madison, Wisconsin, United States
Narayana Nethralaya
🇮🇳Bangalore, Karnataka, India
McDonald Eye Associates
🇺🇸Fayetteville, Arkansas, United States
The Eye Institute of West Florida
🇺🇸Largo, Florida, United States
Ballas Surgery Center
🇺🇸St. Louis, Missouri, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
The Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Island Eye Surgicenter
🇺🇸Carle Place, New York, United States
Wills Surgery Center
🇺🇸Philadelphia, Pennsylvania, United States
The Mehta International Eye Institute & Colaba Eye Hospital
🇮🇳Mumbai, Maharashtra, India
Bhagwan Mahaveer Jain Hospital
🇮🇳Bangalore, Karnataka, India
St. John's Clinic Eye Specialists
🇺🇸Springfield, Missouri, United States