DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

This study has been completed.
Sponsor:
Information provided by:
Aqumen Biopharmaceuticals, N.A.
ClinicalTrials.gov Identifier:
NCT00596583
First received: January 9, 2008
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Mature Cataracts
Drug: DYME
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aqumen Biopharmaceuticals, N.A.:

Primary Outcome Measures:
  • 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: one week post-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596583

Locations
United States, Arkansas
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
United States, California
Peace Laser Eye Center
Inglewood, California, United States, 90301
Capitol City Surgery Center
Sacramento, California, United States, 95815
United States, Florida
The Eye Institute of West Florida
Largo, Florida, United States, 33770
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Missouri
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
Wills Eye Surgery Center
Cherry Hill, New Jersey, United States, 08002
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, Ohio
The Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
Wills Surgery Center
Philadelphia, Pennsylvania, United States, 19145
Wills Eye Surgery Center
Philadelphia, Pennsylvania, United States, 19107
United States, Wisconsin
SMDV Surgery Center
Madison, Wisconsin, United States, 53715
India
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
The Mehta International Eye Institute & Colaba Eye Hospital
Mumbai, Maharashtra, India, 400 005
Sponsors and Collaborators
Aqumen Biopharmaceuticals, N.A.
Investigators
Study Director: Hardy Kagimoto, M.D. Aqumen Biopharmaceuticals, N.A.
  More Information

No publications provided

Responsible Party: Hardy Kagimoto, M.D. / C.E.O., Aqumen Biopharmaceuticals, N.A.
ClinicalTrials.gov Identifier: NCT00596583     History of Changes
Other Study ID Numbers: AQNA-DY001, US IND 75,735
Study First Received: January 9, 2008
Last Updated: February 27, 2009
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014