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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
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 Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00961051Evaluation of an Investigational Multi-Purpose Solution (MPS)PHASE3 COMPLETED 270Feb 1, 2009Nov 1, 2009Jan 7, 20149 United States
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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 — 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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