Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BOL-303242-X · 1 trial · 2 indications
Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
| Arm | Type | Description |
|---|---|---|
| BOL-303242-X | EXPERIMENTAL | BOL-303242-X (Mapracorat) |
| Vehicle | PLACEBO_COMPARATOR | Vehicle for BOL-303242-X (Mapracorat) |
| Name | Type | Description |
|---|---|---|
| BOL-303242-X | DRUG | Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules. |
| Vehicle for BOL-303242-X | DRUG | Medication instilled into the study eye, subjects randomized to various drug dose schedules. |
Inclusion Criteria: * Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent. * Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC)...
BOL-303242-X is an investigational small molecule being developed for the treatment of inflammation following cataract surgery. It is intended to address the inflammatory response that occurs after the surgical procedure, with the goal of managing this common postoperative complication.
BOL-303242-X is being developed by Bausch + Lomb Corporation, a company traded on the stock exchange under the ticker symbol BLCO. The company is conducting clinical research to evaluate the drug's safety and efficacy for its intended use in cataract surgery patients.
BOL-303242-X is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating inflammation following cataract surgery.
BOL-303242-X has been studied in one completed Phase 2 clinical trial with the identifier NCT00905450. This trial evaluated the drug versus a vehicle control for the treatment of inflammation following cataract surgery, enrolling 415 participants in the United States.
BOL-303242-X is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this compound in the available clinical trial information, so it is not known to be identical to any other marketed or investigational drug.