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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

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

B & L Soothe Lubricant Eye · 1 trial · 1 indication

Early Phase 1 1
NCT01375582Objective Evaluation of Ocular Surface Lubricants in Two EnvironmentsDry Eye
COMPLETED20 Analytics
EARLY_PHASE1COMPLETED
Objective Evaluation of Ocular Surface Lubricants in Two Environments
Dry EyeUnlock trial analytics

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 to 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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Frequently asked questions about B & L Soothe Lubricant Eye

What is B & L Soothe Lubricant Eye used for?

B & L Soothe Lubricant Eye is used for dry eye. It is an investigational small molecule being developed by Bausch + Lomb Corporation for the treatment of dry eye. The drug is currently in early Phase 1 clinical development.

Who makes B & L Soothe Lubricant Eye?

Bausch + Lomb Corporation (NYSE: BLCO) is developing B & L Soothe Lubricant Eye. The company is conducting clinical research on this lubricant eye product for dry eye.

What phase is B & L Soothe Lubricant Eye in?

B & L Soothe Lubricant Eye is in early Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One early Phase 1 trial has been completed.

What clinical trials is B & L Soothe Lubricant Eye in?

B & L Soothe Lubricant Eye has one completed clinical trial, NCT01375582, titled "Objective Evaluation of Ocular Surface Lubricants in Two Environments." This early Phase 1 study enrolled 20 participants with dry eye in the United States.

Is B & L Soothe Lubricant Eye FDA approved?

B & L Soothe Lubricant Eye is not FDA approved. It is an investigational product currently in early Phase 1 clinical development. The completed trial was a double-blind, uncontrolled study evaluating the ocular surface lubricant.