DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery (AQNA-DY002)

Aqumen Biopharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Mature Cataracts

Treatments

Drug: DYME

Study type

Interventional

Funder types

Industry

Identifiers

NCT00596492

US IND 75,735

AQNA-DY002

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.