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0.3% BOL-303242-X

Phase 2

Dry Eye Syndrome | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Trials Updated: Sep 25, 2020

0.3% BOL-303242-X target and mechanism

ModalitySmall molecule

Also known as 0.3% BOL-303242-X ophthalmic suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment356

FDA Designations

No designations recorded

0.3% BOL-303242-X clinical trials

0.3% BOL-303242-X · 1 trial · 1 indication

Phase 2 1
NCT01163643Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye SyndromeDry Eye Syndrome
COMPLETED356 Analytics
PHASE2COMPLETED
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Dry Eye SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Corneal Staining Score
12 weeks

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.

Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
12 weeks

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.3% BOL-303242-X ophthalmic suspensionEXPERIMENTAL0.3% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspensionEXPERIMENTAL2% BOL-303242-X ophthalmic suspension
VehiclePLACEBO_COMPARATORVehicle twice daily (BID)
1% BOL-303242-X ophthalmic suspensionEXPERIMENTAL1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension in the morningEXPERIMENTAL2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension PMEXPERIMENTALVehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Interventions

NameTypeDescription
0.3% BOL-303242-X ophthalmic suspensionDRUG0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
2% BOL-303242-X ophthalmic suspensionDRUG2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Placebo Comparator: VehicleDRUGPlacebo Comparator: Vehicle BID for 12 weeks.
1% BOL-303242-X ophthalmic suspensionDRUG1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
2% BOL-303242-X ophthalmic suspension AMDRUG2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
2% BOL-303242-X ophthalmic suspension PMDRUGVehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Competitive Landscape -Acute Respiratory Distress Syndrome 27 trials (matched to "Dry Eye Syndrome")

Top 2 of 7 competitors

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Frequently asked questions about 0.3% BOL-303242-X

What is 0.3% BOL-303242-X?

0.3% BOL-303242-X is an investigational small molecule ophthalmic suspension being developed by Bausch + Lomb Corporation for Dry Eye Syndrome. It is a sterile topical eye drop formulation. The asset has completed a single Phase 2 clinical trial and is not approved for commercial use.

What is 0.3% BOL-303242-X used for?

0.3% BOL-303242-X is being studied for the treatment of Dry Eye Syndrome, an ophthalmology condition. Its only recorded clinical trial enrolled adults 18 years and older with Dry Eye Syndrome in the United States. The drug remains investigational and has not been cleared for any approved use.

Who makes 0.3% BOL-303242-X?

Bausch + Lomb Corporation develops 0.3% BOL-303242-X. The company trades on the New York Stock Exchange under the ticker BLCO. Bausch + Lomb is an eye health company, and this ophthalmic suspension sits within its ophthalmology pipeline as an investigational Phase 2 asset.

What phase is 0.3% BOL-303242-X in?

0.3% BOL-303242-X is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. Because the program has not advanced beyond Phase 2, the drug is investigational and has not received FDA approval for Dry Eye Syndrome.

What clinical trials is 0.3% BOL-303242-X in?

0.3% BOL-303242-X has been evaluated in one completed Phase 2 study, NCT01163643, titled Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome. The trial was randomized, double blind, and placebo controlled, enrolling 356 participants in the United States.

Is 0.3% BOL-303242-X the same as 0.3% BOL-303242-X ophthalmic suspension?

Yes. 0.3% BOL-303242-X ophthalmic suspension is the same asset as 0.3% BOL-303242-X. The longer name describes the topical eye drop dosage form used in the Phase 2 Dry Eye Syndrome trial, while the shorter name is the drug identifier used in pipeline references.