Clinical trial NCT00596583: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mature Cataracts
Lead sponsor: Aqumen Biopharmaceuticals, N.A.
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
timeFrame: During surgery
measure: Uncomplicated discharge
timeFrame: one week post-op
Secondary outcomes:
measure: Quality of stain
timeFrame: during surgery
measure: 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
timeFrame: 1-day and 1-week post-op
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: McDonald Eye Associates
state: Arkansas
city: Inglewood
country: United States
facility: Peace Laser Eye Center
state: California
city: Sacramento
country: United States
facility: Capitol City Surgery Center
state: California
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Springfield
country: United States
facility: St. John's Clinic Eye Specialists
state: Missouri
city: St. Louis
country: United States
facility: Ballas Surgery Center
state: Missouri
city: Cherry Hill
country: United States
facility: Wills Eye Surgery Center
state: New Jersey
city: West Paterson
country: United States
facility: Brar-Parekh Eye Associates
state: New Jersey
city: Carle Place
country: United States
facility: Island Eye Surgicenter
state: New York
city: Columbus
country: United States
facility: The Ohio State University Hospital
state: Ohio
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Surgery Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Surgery Center
state: Pennsylvania
city: Madison
country: United States
facility: SMDV Surgery Center
state: Wisconsin
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Hospital
state: Karnataka
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Mumbai
country: India
facility: The Mehta International Eye Institute & Colaba Eye Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Bombay City Eye Institute & Research Centre
state: Maharashtra
Study officials:
affiliation: Aqumen Biopharmaceuticals, N.A.
name: Hardy Kagimoto, M.D.
role: STUDY_DIRECTOR
References: