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BSS Plus

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment387
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00346528Safety of NGOIS Compared to BSS Plus in Pediatric PatientsPHASE3 COMPLETED 18 — — Jul 1, 2006Jun 1, 2007Mar 5, 20121 United States
NCT00333268Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS PlusPHASE3 COMPLETED 369 — — Sep 1, 2004Jul 1, 2005Mar 5, 20121 United States
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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 — 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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