A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-11-30

Brief Summary

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A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Intervention Type DRUG

Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks

Arm 2

Group Type ACTIVE_COMPARATOR

Lifitegrast

Intervention Type DRUG

Topical ocular drop of lifitegrast administered for 4 weeks

Arm 3

Group Type ACTIVE_COMPARATOR

Perfluorohexyloctane

Intervention Type DRUG

Topical ocular drop of perfluorohexyloctane administered for 4 weeks

Arm 4

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical ocular drop with no active ingredients administered for 4 weeks

Arm 5

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical ocular drop with no active ingredients administered for 4 weeks

Arm 6

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical ocular drop with no active ingredients administered for 4 weeks

Interventions

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Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks

Intervention Type DRUG

Lifitegrast

Topical ocular drop of lifitegrast administered for 4 weeks

Intervention Type DRUG

Perfluorohexyloctane

Topical ocular drop of perfluorohexyloctane administered for 4 weeks

Intervention Type DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

Intervention Type DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

Intervention Type DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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 following criteria for dry eye signs at both screening and baseline/randomization
* The criteria for dry eye symptoms are met at both screening and baseline/randomization
* As needed (PRN) or scheduled use of non-prescription (OTC) artificial tear, gels, or lubricants for symptoms of dry eye within the past 30 days
* Able and willing to follow instructions, including participation in all trial assessments and visits

Exclusion Criteria

* Known allergy or sensitivity to any study treatment (or any of its components)
* Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
* Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
* Use of any of any ocular therapies within 30 days.
* Unable or unwilling to stop current topical dry eye treatments

Additional criteria per protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No