Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.3% BOL-303242-X · 1 trial · 1 indication
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.
| Arm | Type | Description |
|---|---|---|
| 0.3% BOL-303242-X ophthalmic suspension | EXPERIMENTAL | 0.3% BOL-303242-X ophthalmic suspension |
| 2% BOL-303242-X ophthalmic suspension | EXPERIMENTAL | 2% BOL-303242-X ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | Vehicle twice daily (BID) |
| 1% BOL-303242-X ophthalmic suspension | EXPERIMENTAL | 1% BOL-303242-X ophthalmic suspension |
| 2% BOL-303242-X ophthalmic suspension in the morning | EXPERIMENTAL | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) |
| 2% BOL-303242-X ophthalmic suspension PM | EXPERIMENTAL | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. |
| Name | Type | Description |
|---|---|---|
| 0.3% BOL-303242-X ophthalmic suspension | DRUG | 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| 2% BOL-303242-X ophthalmic suspension | DRUG | 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| Placebo Comparator: Vehicle | DRUG | Placebo Comparator: Vehicle BID for 12 weeks. |
| 1% BOL-303242-X ophthalmic suspension | DRUG | 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. |
| 2% BOL-303242-X ophthalmic suspension AM | DRUG | 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. |
| 2% BOL-303242-X ophthalmic suspension PM | DRUG | Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. |
Inclusion Criteria: * Subjects who have a diagnosis of dry eye disease. * Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications. * Subjects who are willing and able to refrain from using contact lenses during the study. Exclusion Criteria: * Subjects with known hypersensitivity or ...
BOL-303242-X is an investigational small molecule being developed for the treatment of Dry Eye Syndrome. It is formulated as a 0.3% ophthalmic suspension and is currently in clinical development, having completed a Phase 2 trial.
BOL-303242-X is being developed by Bausch + Lomb Corporation, a company traded on the stock exchange under the ticker symbol BLCO. The drug is an investigational ophthalmic treatment for Dry Eye Syndrome.
BOL-303242-X is in Phase 2 of clinical development. It has completed a Phase 2 clinical trial for Dry Eye Syndrome, and it remains an investigational drug that has not been approved by regulatory authorities.
BOL-303242-X has been studied in one completed Phase 2 clinical trial, identified as NCT01163643. This trial assessed the safety and efficacy of BOL-303242-X ophthalmic suspension in Dry Eye Syndrome and enrolled 356 participants in the United States.
Yes, BOL-303242-X and 0.3% BOL-303242-X refer to the same investigational drug. The 0.3% designation indicates the concentration of the active ingredient in the ophthalmic suspension formulation being developed for Dry Eye Syndrome.