Mature Cataracts
Conditions
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.
Interventions
DRUGDYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
Sponsors
Aqumen Biopharmaceuticals, N.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
Design outcomes
Primary
| 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 | Three months post-op |
Secondary
| 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 |
| Intra-ocular safety of DYME as measured by corneal endothelial cell count | Three months post-op |
Countries
India, United States
Outcome results
None listed