Trial | NCT00596583  Report issue

Title

DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
AQNA-DY001: A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
Study Started
Apr 30
2007
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Mar 02
2009
Estimate

Drug DYME

2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution

Drug DYME

2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution

High Dose Active Comparator

Low Dose Active Comparator

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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.
No Results Posted