Recent Updates
Recently added Catalysts

Next Generation Irrigating

Phase 3

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

Next Generation Irrigating 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 Trials3
Total Enrollment756

FDA Designations

No designations recorded

Next Generation Irrigating clinical trials

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
CataractUnlock trial analytics
PHASE3COMPLETED
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
Eye DiseasesUnlock 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
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

Frequently asked questions about Next Generation Irrigating

What is Next Generation Irrigating?

Next Generation Irrigating is an investigational small molecule ophthalmic irrigating solution developed by Alcon Inc. (ticker ALC). It is designed for use during eye surgery, including cataract procedures and other eye diseases, where it serves as the fluid used to maintain the surgical field. It is also known as Next Generation Ophthalmic Irrigating Solution (NGOIS).

What is Next Generation Irrigating used for in cataract surgery?

Next Generation Irrigating is being developed for use as an irrigating solution during cataract surgery and other eye disease procedures. In this role it maintains the internal environment of the eye during ophthalmic surgery. Its clinical program has studied it in cataract patients, including both adult and pediatric populations, in the United States.

Who makes Next Generation Irrigating?

Next Generation Irrigating is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating the solution, including the Phase 3 studies conducted in the United States. The asset is also referred to as Next Generation Ophthalmic Irrigating Solution (NGOIS).

What phase is Next Generation Irrigating in?

Next Generation Irrigating is in Phase 3 development. Its clinical program includes completed Phase 3 trials, and no trials are currently listed as active. The studies were randomized, double blind, and active controlled, comparing the solution against BSS Plus in patients undergoing cataract surgery and in patients with eye diseases.

What clinical trials is Next Generation Irrigating in?

Next Generation Irrigating has been studied in completed Phase 3 trials, including NCT00346528, which evaluated safety compared to BSS Plus in pediatric cataract patients, and NCT00333268, which assessed safety and efficacy compared to BSS Plus in adults with cataract. A third study, NCT00333203, examined the solution in posterior segment eye disease.

Is Next Generation Irrigating the same as Next Generation Ophthalmic Irrigating Solution?

Yes. Next Generation Irrigating and Next Generation Ophthalmic Irrigating Solution (NGOIS) refer to the same Alcon Inc. (ticker ALC) asset. NGOIS is the full name used in the clinical trial titles, while Next Generation Irrigating is the shorter form. Both describe the same investigational ophthalmic irrigating solution in Phase 3 development.