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| ID | Type | Description | Link |
|---|---|---|---|
| US IND 75,735 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Active Comparator |
| |
| Low Dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DYME | Drug | 2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hardy Kagimoto, M.D. | Aqumen Biopharmaceuticals, N.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDonald Eye Associates | Fayetteville | Arkansas | 72703 | United States | ||
| Peace Laser Eye Center |
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| DYME |
| Drug |
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution |
|
| 1-day and 1-week post-op |
| Inglewood |
| California |
| 90301 |
| United States |
| Capitol City Surgery Center | Sacramento | California | 95815 | United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| Eye Surgeons of Indiana | Indianapolis | Indiana | 46256 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| St. John's Clinic Eye Specialists | Springfield | Missouri | 65804 | United States |
| Ballas Surgery Center | St Louis | Missouri | 63141 | United States |
| Wills Eye Surgery Center | Cherry Hill | New Jersey | 08002 | United States |
| Brar-Parekh Eye Associates | Woodland Park | New Jersey | 07424 | United States |
| Island Eye Surgicenter | Carle Place | New York | 11514 | United States |
| The Ohio State University Hospital | Columbus | Ohio | 43210 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Wills Eye Surgery Center | Philadelphia | Pennsylvania | 19107 | United States |
| Wills Surgery Center | Philadelphia | Pennsylvania | 19145 | United States |
| SMDV Surgery Center | Madison | Wisconsin | 53715 | United States |
| Narayana Nethralaya | Bangalore | Karnataka | 560020 | India |
| Bhagwan Mahaveer Jain Hospital | Bangalore | Karnataka | 560052 | India |
| Narayana Nethralaya | Bangalore | Karnataka | 560099 | India |
| The Mehta International Eye Institute & Colaba Eye Hospital | Mumbai | Maharashtra | 400 005 | India |
| Bombay City Eye Institute & Research Centre | Mumbai | Maharashtra | 400 007 | India |