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Recently added Catalysts

DisCoVisc, DuoVisc, BioVisc, Healon5, Amvisc Plus

Phase 3

Cataracts | Unknown | Ophthalmology |Alcon Inc.|Last Updated: Jul 30, 2010

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment173

FDA Designations

No designations recorded

Clinical trial landscape

DisCoVisc, DuoVisc, BioVisc, Healon5, Amvisc Plus · 1 trial · 1 indication

Phase 3 1
NCT00732225DisCoVisc Comparative EvaluationCataracts
COMPLETED173 Analytics
PHASE3COMPLETED
DisCoVisc Comparative Evaluation
CataractsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Loss of Endothelial Cells
2 months following surgery

Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.

Secondary Endpoints

Aqueous Signs - Corneal Edema
1 day after surgery
Aqueous Signs - Aqueous Flare
1 day following surgery
Aqueous Signs - Aqueous Cells
1 day following surgery
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DisCoViscACTIVE_COMPARATORAlcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoViscACTIVE_COMPARATORAlcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioViscACTIVE_COMPARATORSophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5ACTIVE_COMPARATORAMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Amvisc PlusACTIVE_COMPARATORBausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Interventions

NameTypeDescription
DisCoViscDEVICEDisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
DuoViscDEVICEDuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
BioViscDEVICEBioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Healon5DEVICEHealon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Amvisc PlusDEVICEAmvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
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Eligibility Criteria

Age Range49 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Unilateral operable cataracts Exclusion Criteria: * Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2 * Intraocular Pressure (IOP) \> 21 * History of ocular inflammation * Systemic or ocular diseases affecting corneal endothelium

Countries:United States
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Frequently asked questions about DisCoVisc, DuoVisc, BioVisc, Healon5, Amvisc Plus

What is DisCoVisc used for?

DisCoVisc is an ophthalmic viscosurgical device used during cataract surgery. It is designed to help maintain space and protect ocular tissues during the procedure. The drug is being developed by Alcon Inc. for the treatment of cataracts.

Who makes DisCoVisc?

DisCoVisc is developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. The company is conducting clinical development of the product for use in cataract surgery.

What phase is DisCoVisc in?

DisCoVisc is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. The Phase 3 trial for DisCoVisc has been completed.

What clinical trials is DisCoVisc in?

DisCoVisc has one completed Phase 3 clinical trial registered under NCT00732225, titled "DisCoVisc Comparative Evaluation." The trial enrolled 173 participants with cataracts in the United States and was actively controlled, meaning it compared DisCoVisc against another treatment.

Is DisCoVisc the same as DuoVisc, BioVisc, Healon5, or Amvisc Plus?

DisCoVisc, DuoVisc, BioVisc, Healon5, and Amvisc Plus are all ophthalmic viscosurgical devices used in cataract surgery. They are distinct products, though they may be used for similar purposes during the procedure.