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Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Trials Updated: Jul 14, 2026

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2025

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination target and mechanism

Molecular targetITGAL, ITGB2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment443

FDA Designations

No designations recorded

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination clinical trials

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination · 1 trial · 1 indication

Phase 2 1
NCT07128628A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye DiseaseDry Eye Disease
COMPLETED443 Analytics
PHASE2COMPLETED
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
Dry Eye DiseaseUnlock trial analytics

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 to 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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Competitive Landscape -Dry Eye Disease 8 trials

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Recent Changes (Last 90 Days)

MEDIUMAug 14, 2026NCT07128628TRIAL_REMOVED: changed
MEDIUMAug 14, 2026NCT07128628TRIAL_REMOVED: changed
MEDIUMAug 14, 2026NCT07128628TRIAL_REMOVED: changed

Frequently asked questions about Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

What is the lifitegrast/perfluorohexyloctane fixed dose combination?

It is an investigational small molecule fixed dose combination developed by Bausch + Lomb Corporation for dry eye disease. The combination pairs lifitegrast with perfluorohexyloctane in a single formulation. It has been studied in a Phase 2 clinical trial and is not approved for marketing.

What is the lifitegrast/perfluorohexyloctane fixed dose combination used for?

The lifitegrast/perfluorohexyloctane fixed dose combination is being developed for dry eye disease. A Phase 2 study evaluated it in adults with this condition. It remains investigational and is not approved for commercial use in any indication.

What does the lifitegrast/perfluorohexyloctane fixed dose combination target?

Lifitegrast, one component of the combination, targets ITGAL and ITGB2, also known as LFA-1 and CD18, and acts as an antagonist. Perfluorohexyloctane is the second component of the fixed dose formulation. The combination is designed to address dry eye disease through these combined mechanisms.

Who is developing the lifitegrast/perfluorohexyloctane fixed dose combination?

Bausch + Lomb Corporation, which trades under the ticker BLCO, is the developer of the lifitegrast/perfluorohexyloctane fixed dose combination. The company is studying the formulation for dry eye disease.

What phase is the lifitegrast/perfluorohexyloctane fixed dose combination in?

The lifitegrast/perfluorohexyloctane fixed dose combination is in Phase 2 development. One Phase 2 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is the lifitegrast/perfluorohexyloctane fixed dose combination in?

One trial has studied the lifitegrast/perfluorohexyloctane fixed dose combination: NCT07128628, a completed Phase 2 study titled A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease. It enrolled 443 participants in the United States in a randomized, double-blind, placebo-controlled design.