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DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery (AQNA-DY002)
This study has been terminated.
( Terminated due to reasons unrelated to safety )
Study NCT00596492   Information provided by Aqumen Biopharmaceuticals, N.A.
First Received: January 9, 2008   Last Updated: February 27, 2009   History of Changes

January 9, 2008
February 27, 2009
May 2008
September 2008   (final data collection date for primary outcome measure)
  • Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • Uncomplicated discharge [ Time Frame: Three months post-op ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00596492 on ClinicalTrials.gov Archive Site
  • Quality of stain [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Intra-ocular safety of DYME as measured by corneal endothelial cell count [ Time Frame: Three months post-op ] [ Designated as safety issue: Yes ]
Same as current
 
DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Mature Cataracts
Drug: DYME
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
200
December 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00596492
Hardy Kagimoto, M.D. / C.E.O., Aqumen Biopharmaceuticals, N.A.
AQNA-DY002, US IND 75,735
Aqumen Biopharmaceuticals, N.A.
 
Study Director: Hardy Kagimoto, M.D. Aqumen Biopharmaceuticals, N.A.
Aqumen Biopharmaceuticals, N.A.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP