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

Last updated: February 27, 2009
Sponsor: Aqumen Biopharmaceuticals, N.A.
Overall Status: Terminated

Phase

3

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

N/A

Clinical Study ID

NCT00596492
AQNA-DY002
US IND 75,735
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon'sassessment,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

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 activeinfection, symptomatic congestive heart failure, unstable angina pectoris, or cardiacarrhythmia;

  • 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 therapeuticduring 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 theresearch subject's safety or ability to participate in the study.

Study Design

Total Participants: 200
Study Start date:
May 01, 2008
Estimated Completion Date:
December 31, 2008

Connect with a study center

  • LV Prasad Eye Institute

    Hyderabaad, Andhra Pradesh 500034
    India

    Site Not Available

  • Bhagwan Mahaveer Jain Hospital

    Bangalore, Karnataka 560052
    India

    Site Not Available

  • Narayana Nethralaya

    Bangalore, Karnataka 560099
    India

    Site Not Available

  • Bombay City Eye Institute & Research Centre

    Mumbai, Maharashtra 400 007
    India

    Site Not Available

  • Sankara Nethralaya

    Chennai, Tamilnadu 600006
    India

    Site Not Available

  • Peace Laser Eye Center

    Inglewood, California 90301
    United States

    Site Not Available

  • Center for Excellence in Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd.

    Des Peres, Missouri 63131
    United States

    Site Not Available

  • Silverstein Eye Centers

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • St. John's Clinic Eye Specialists

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Ballas Surgery Center

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Brar-Parekh Eye Associates

    West Paterson, New Jersey 07424
    United States

    Site Not Available

  • Island Eye Surgicenter

    Carle Place, New York 11514
    United States

    Site Not Available

  • Eye Care Specialists

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

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