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

Primary Purpose

Mature Cataracts

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DYME
DYME
Sponsored by
Aqumen Biopharmaceuticals, N.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mature Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McDonald Eye Associates
  • Peace Laser Eye Center
  • Capitol City Surgery Center
  • The Eye Institute of West Florida
  • Center for Excellence in Eye Care
  • Eye Surgeons of Indiana
  • Silverstein Eye Centers
  • St. John's Clinic Eye Specialists
  • Ballas Surgery Center
  • Wills Eye Surgery Center
  • Brar-Parekh Eye Associates
  • Island Eye Surgicenter
  • The Ohio State University Hospital
  • Eye Care Specialists
  • Wills Eye Surgery Center
  • Wills Surgery Center
  • SMDV Surgery Center
  • Narayana Nethralaya
  • Bhagwan Mahaveer Jain Hospital
  • Narayana Nethralaya
  • The Mehta International Eye Institute & Colaba Eye Hospital
  • Bombay City Eye Institute & Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High Dose

Low Dose

Arm Description

Outcomes

Primary Outcome Measures

Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
Uncomplicated discharge

Secondary Outcome Measures

Quality of stain
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

Full Information

First Posted
January 9, 2008
Last Updated
February 27, 2009
Sponsor
Aqumen Biopharmaceuticals, N.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00596583
Brief Title
DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aqumen Biopharmaceuticals, N.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mature Cataracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose
Arm Type
Active Comparator
Arm Title
Low Dose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DYME
Intervention Description
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
DYME
Intervention Description
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
Time Frame
During surgery
Title
Uncomplicated discharge
Time Frame
one week post-op
Secondary Outcome Measure Information:
Title
Quality of stain
Time Frame
during surgery
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hardy Kagimoto, M.D.
Organizational Affiliation
Aqumen Biopharmaceuticals, N.A.
Official's Role
Study Director
Facility Information:
Facility Name
McDonald Eye Associates
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Peace Laser Eye Center
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Capitol City Surgery Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
The Eye Institute of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
St. John's Clinic Eye Specialists
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Ballas Surgery Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Wills Eye Surgery Center
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Brar-Parekh Eye Associates
City
West Paterson
State/Province
New Jersey
ZIP/Postal Code
07424
Country
United States
Facility Name
Island Eye Surgicenter
City
Carle Place
State/Province
New York
ZIP/Postal Code
11514
Country
United States
Facility Name
The Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Wills Eye Surgery Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Wills Surgery Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19145
Country
United States
Facility Name
SMDV Surgery Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Narayana Nethralaya
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560020
Country
India
Facility Name
Bhagwan Mahaveer Jain Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
Narayana Nethralaya
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Name
The Mehta International Eye Institute & Colaba Eye Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 005
Country
India
Facility Name
Bombay City Eye Institute & Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 007
Country
India

12. IPD Sharing Statement

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

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