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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mature Cataracts

Intervention / Treatment
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* Drug: DYME
* Drug: DYME


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose<br> | Drug: DYME<br>* 2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution<br>|
| Active Comparator: Low Dose<br> | Drug: DYME<br>* 2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |