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

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

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.

Study Overview

• Status: Completed
• Conditions: Mature Cataracts
• Intervention / Treatment: Drug: DYME; Drug: DYME

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560052
      • Bhagwan Mahaveer Jain Hospital
    • Bangalore, Karnataka, India, 560020
      • Narayana Nethralaya
    • Bangalore, Karnataka, India, 560099
      • Narayana Nethralaya
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 007
      • Bombay City Eye Institute & Research Centre
    • Mumbai, Maharashtra, India, 400 005
      • The Mehta International Eye Institute & Colaba Eye Hospital
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • McDonald Eye Associates
  • California
    • Inglewood, California, United States, 90301
      • Peace Laser Eye Center
    • Sacramento, California, United States, 95815
      • Capitol City Surgery Center
  • Florida
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
    • Miami, Florida, United States, 33176
      • Center for Excellence in Eye Care
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Eye Surgeons of Indiana
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Springfield, Missouri, United States, 65804
      • St. John's Clinic Eye Specialists
    • St. Louis, Missouri, United States, 63141
      • Ballas Surgery Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Wills Eye Surgery Center
    • West Paterson, New Jersey, United States, 07424
      • Brar-Parekh Eye Associates
  • New York
    • Carle Place, New York, United States, 11514
      • Island Eye Surgicenter
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Hospital
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Surgery Center
    • Philadelphia, Pennsylvania, United States, 19145
      • Wills Surgery Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SMDV Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.	During surgery
Uncomplicated discharge	one week post-op

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of stain	during surgery
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	1-day and 1-week post-op

Collaborators and Investigators

• Sponsor: Aqumen Biopharmaceuticals, N.A.
• Investigators: Study Director: Hardy Kagimoto, M.D., Aqumen Biopharmaceuticals, N.A.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 2, 2009
• Last Update Submitted That Met QC Criteria: February 27, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: AQNA-DY001; US IND 75,735