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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596492
Recruitment Status : Terminated (Terminated due to reasons unrelated to safety)
First Posted : January 17, 2008
Last Update Posted : March 2, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Mature Cataracts Drug: DYME Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AQNA-DY002: 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
Study Start Date : May 2008
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: High Dose Drug: DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
Active Comparator: Low Dose Drug: DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution

Primary Outcome Measures :
  1. Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed. [ Time Frame: During surgery ]
  2. Uncomplicated discharge [ Time Frame: Three months post-op ]

Secondary Outcome Measures :
  1. Quality of stain [ Time Frame: during surgery ]
  2. 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 [ Time Frame: 1-day and 1-week post-op ]
  3. Intra-ocular safety of DYME as measured by corneal endothelial cell count [ Time Frame: Three months post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596492

United States, California
Peace Laser Eye Center
Inglewood, California, United States, 90301
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Missouri
Ophthalmology Consultants, Ltd.
Des Peres, Missouri, United States, 63131
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
St. John's Clinic Eye Specialists
Springfield, Missouri, United States, 65804
Ballas Surgery Center
St. Louis, Missouri, United States, 63141
United States, New Jersey
Brar-Parekh Eye Associates
West Paterson, New Jersey, United States, 07424
United States, New York
Island Eye Surgicenter
Carle Place, New York, United States, 11514
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
LV Prasad Eye Institute
Hyderabaad, Andhra Pradesh, India, 500034
Narayana Nethralaya
Bangalore, Karnataka, India, 560020
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, India, 560052
Narayana Nethralaya
Bangalore, Karnataka, India, 560099
Bombay City Eye Institute & Research Centre
Mumbai, Maharashtra, India, 400 007
Sankara Nethralaya
Chennai, Tamilnadu, India, 600006
Sponsors and Collaborators
Aqumen Biopharmaceuticals, N.A.
Study Director: Hardy Kagimoto, M.D. Aqumen Biopharmaceuticals, N.A.

Responsible Party: Hardy Kagimoto, M.D. / C.E.O., Aqumen Biopharmaceuticals, N.A. Identifier: NCT00596492     History of Changes
Other Study ID Numbers: AQNA-DY002
US IND 75,735
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: March 2, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions