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BSS Plus

Phase 3

Cataract | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Mar 5, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment387

FDA Designations

No designations recorded

Clinical trial landscape

BSS Plus · 2 trials · 1 indication

Phase 3 2
NCT00346528Safety of NGOIS Compared to BSS Plus in Pediatric PatientsCataract
COMPLETED18 Analytics
NCT00333268Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS PlusCataract
COMPLETED369 Analytics
PHASE3COMPLETED
Safety of NGOIS Compared to BSS Plus in Pediatric Patients
CataractUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
CataractUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
Percent change in endothelial cell density

Secondary Endpoints

Best corrected logMAR visual acuity
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NGOISEXPERIMENTAL -
BSS PlusACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Next Generation Ophthalmic Irrigating Solution (NGOIS)DRUGVolume sufficient to irrigate adequately during cataract surgery
BSS PlusDRUGVolume sufficient to irrigate adequately during cataract surgery
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Eligibility Criteria

Age Range1 Week to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Cataract present. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * As per age requirements. * Other protocol-defined exclusion criteria may apply.

Countries:United States
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Frequently asked questions about BSS Plus

What is BSS Plus used for?

BSS Plus is an ophthalmic irrigating solution used during cataract surgery. It is developed by Alcon Inc. and is in Phase 3 clinical development for the treatment of cataract. The solution is intended to maintain the health of ocular tissues during surgical procedures.

Who makes BSS Plus?

BSS Plus is developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device company specializing in eye care products, including surgical equipment and pharmaceuticals.

What phase is BSS Plus in?

BSS Plus is in Phase 3 clinical development. It has completed two Phase 3 trials, one involving 369 adult patients and another involving 18 pediatric patients, both conducted in the United States for cataract surgery. The drug is investigational and not yet approved.

What clinical trials is BSS Plus in?

BSS Plus has completed two Phase 3 trials. NCT00333268 evaluated the safety and efficacy of a next generation ophthalmic irrigating solution compared to BSS Plus in 369 cataract patients. NCT00346528 assessed the safety of the same solution compared to BSS Plus in 18 pediatric cataract patients.

Is BSS Plus the same as NGOIS?

BSS Plus is not the same as NGOIS (Next Generation Ophthalmic Irrigating Solution). In clinical trials, NGOIS was the investigational product being compared against BSS Plus, which served as the active control. Both are ophthalmic irrigating solutions used during cataract surgery.