Approval Probability
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Also known as Mapracorat
BOL-303242-X · 6 trials · 5 indications
Anterior chamber (AC) cells were 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. 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.
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.
Anterior chamber (AC) cells were 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. 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.
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
The mean endothelial cell density (cells/mm2)(ECD)
| Arm | Type | Description |
|---|---|---|
| Mapracorat | EXPERIMENTAL | Mapracorat ophthalmic suspension, 3%, |
| Vehicle | PLACEBO_COMPARATOR | The vehicle of the mapracorat ophthalmic suspension |
| Mapracorat Vehicle | PLACEBO_COMPARATOR | - |
| BOL-303242-X | EXPERIMENTAL | BOL-303242-X (Mapracorat) |
| Name | Type | Description |
|---|---|---|
| Mapracorat | DRUG | 1 drop of study medication into the study eye QID for 14 days |
| Placebo | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
| Vehicle | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
| 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 who are candidates for routine, uncomplicated cataract surgery. * Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. * Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in...
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.