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

Mature Cataracts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596583
• Other study ID #: AQNA-DY001
• Secondary ID: US IND 75,735
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: February 27, 2009
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Aqumen Biopharmaceuticals, N.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cataract
• Mature Cataracts

Intervention

Drug:
• DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
• DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution

Locations

Country	Name	City	State
India	Bhagwan Mahaveer Jain Hospital	Bangalore	Karnataka
India	Narayana Nethralaya	Bangalore	Karnataka
India	Narayana Nethralaya	Bangalore	Karnataka
India	Bombay City Eye Institute & Research Centre	Mumbai	Maharashtra
India	The Mehta International Eye Institute & Colaba Eye Hospital	Mumbai	Maharashtra
United States	Island Eye Surgicenter	Carle Place	New York
United States	Wills Eye Surgery Center	Cherry Hill	New Jersey
United States	The Ohio State University Hospital	Columbus	Ohio
United States	McDonald Eye Associates	Fayetteville	Arkansas
United States	Eye Surgeons of Indiana	Indianapolis	Indiana
United States	Peace Laser Eye Center	Inglewood	California
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	The Eye Institute of West Florida	Largo	Florida
United States	SMDV Surgery Center	Madison	Wisconsin
United States	Center for Excellence in Eye Care	Miami	Florida
United States	Wills Eye Surgery Center	Philadelphia	Pennsylvania
United States	Wills Surgery Center	Philadelphia	Pennsylvania
United States	Capitol City Surgery Center	Sacramento	California
United States	St. John's Clinic Eye Specialists	Springfield	Missouri
United States	Ballas Surgery Center	St. Louis	Missouri
United States	Brar-Parekh Eye Associates	West Paterson	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Aqumen Biopharmaceuticals, N.A.

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.		During surgery	No
Primary	Uncomplicated discharge		one week post-op	Yes
Secondary	Quality of stain		during surgery	No
Secondary	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	Yes