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B & L Soothe Lubricant Eye

Phase 1

Dry Eye | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Nov 22, 2022

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
Double-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01375582Objective Evaluation of Ocular Surface Lubricants in Two EnvironmentsEARLY_PHASE1 COMPLETED 20Jun 1, 2011Jun 1, 2012Nov 22, 20221 United States
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Study Endpoints
Primary Endpoints
Tear Film Properties
Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.

The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes. A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.

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Study Design & Arms
AllocationNA
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drop AdministrationEXPERIMENTAL -
Interventions
NameTypeDescription
B & L Soothe Lubricant Eye DropsDRUGEye Drop
Liposic EDODRUGEye Drop
OcuFresh Eye WashDRUGSaline drop
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 30-75 years * Good general health * Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits * Currently using an OTC artificial tear for ocular comfort, at least occasionally. * At least one positi...

Countries:United States
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