Recent Updates
Recently added Catalysts

Next Generation Irrigating

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Next Generation Ophthalmic Irrigating Solution (NGOIS)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment387

FDA Designations

No designations recorded

Clinical trial landscape

Next Generation Irrigating · 3 trials · 2 indications

Phase 3 3
NCT00346528Safety of NGOIS Compared to BSS Plus in Pediatric PatientsCataract
COMPLETED18 Analytics
NCT00333203Next Generation Ophthalmic Irrigating Solution Posterior Segment StudyEye Diseases
COMPLETED369 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
Cataract
NCT0034652818
Unlock trial analytics
PHASE3COMPLETED
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
Eye Diseases
NCT00333203369
Unlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
Cataract
NCT00333268369
Unlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Intraocular pressure (IOP)
Best corrected logMAR visual acuity
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria