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Investigational MPS, Opti-Free

Phase 3

Study Focus is Healthy Contact Lens Wearers | Unknown | Other |Abbott Laboratories|Last Updated: Jan 7, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

Investigational MPS, Opti-Free · 1 trial · 1 indication

Phase 3 1
NCT00961051Evaluation of an Investigational Multi-Purpose Solution (MPS)Study Focus is Healthy Contact Lens Wearers
COMPLETED270 Analytics
PHASE3COMPLETED
Evaluation of an Investigational Multi-Purpose Solution (MPS)
Study Focus is Healthy Contact Lens WearersUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Lens Cleanliness as Measured by Light Reflectance
Day 30

Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).

Secondary Endpoints

Number of Subjects With no Corneal Staining
Day 180
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Investigational MPSEXPERIMENTALInvestigational multipurpose disinfecting solution (study MPS)
Predicate MPSACTIVE_COMPARATOROpti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)

Interventions

NameTypeDescription
Investigational MPSDEVICEMulti-purpose solution
Opti-FreeDEVICEMulti-purpose solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * Have successfully worn hydrogel contact lenses of the same material to be worn during the study * Have normal eyes (with the exception of unaided visual acuity) * Have successfully used a multi-purpose contact lens care solution * Have acceptable visual acuity and lens wearing...

Countries:United States
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Frequently asked questions about Investigational MPS, Opti-Free

What is the investigational MPS, Opti-Free used for?

The investigational MPS, Opti-Free is a multi-purpose solution being studied for use in healthy contact lens wearers. It is intended for contact lens care, though the specific formulation and indications are part of an ongoing clinical evaluation.

Who makes the investigational MPS, Opti-Free?

Abbott Laboratories (NYSE: ABT) is developing the investigational MPS, Opti-Free. The company is conducting clinical trials to evaluate this multi-purpose solution for contact lens care.

What phase is the investigational MPS, Opti-Free in?

The investigational MPS, Opti-Free is in Phase 3 clinical development. It is not FDA approved and remains investigational, with a completed Phase 3 trial evaluating its use in healthy contact lens wearers.

What clinical trials is the investigational MPS, Opti-Free in?

The investigational MPS, Opti-Free has one completed Phase 3 trial, NCT00961051, titled "Evaluation of an Investigational Multi-Purpose Solution (MPS)." This randomized, double-blind, active-controlled study enrolled 270 healthy contact lens wearers in the United States.

Is the investigational MPS, Opti-Free the same as Opti-Free?

The investigational MPS, Opti-Free is being studied as a multi-purpose solution, and its name suggests a connection to the Opti-Free brand. However, it is an investigational product, distinct from commercially available Opti-Free solutions, pending clinical evaluation results.