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Perfluorohexyloctane

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Mar 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment423
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07128628A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye DiseasePHASE2 RECRUITING 423Oct 24, 2025Nov 1, 2026Mar 13, 202632 United States
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Study Endpoints
Primary Endpoints
Total corneal fluorescein staining change from baseline
Baseline, day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -
Arm 4PLACEBO_COMPARATOR -
Arm 5PLACEBO_COMPARATOR -
Arm 6PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Lifitegrast/Perfluorohexyloctane Fixed Dose CombinationDRUGTopical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
LifitegrastDRUGTopical ocular drop of lifitegrast administered for 4 weeks
PerfluorohexyloctaneDRUGTopical ocular drop of perfluorohexyloctane administered for 4 weeks
VehicleDRUGTopical ocular drop with no active ingredients administered for 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: This study will include subjects who meet all of the following inclusion criteria: * Voluntarily provide written informed consent * ≥18 years of age * Subject-reported history of DED OU for at least 6 months * Same eye satisfies the criteria for dry eye signs at both screening ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07128628primaryCompletionDate: changed
LOWMay 24, 2026NCT07128628studyFirstPostDate: changed