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

Bausch + Lomb

Status and phase: Not yet enrolling; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: Vehicle; Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination; Drug: Perfluorohexyloctane; Drug: Lifitegrast

Study type: Interventional

Funder types: Industry

Identifiers

NCT07128628

BL-RX01-OPUSNG-1201

Details and patient eligibility

About

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

Enrollment: 423 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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423 participants in 6 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Arm 2

Active Comparator group

Treatment:

Drug: Lifitegrast

Arm 3

Active Comparator group

Treatment:

Drug: Perfluorohexyloctane

Arm 4

Placebo Comparator group

Treatment:

Drug: Vehicle

Drug: Vehicle

Drug: Vehicle

Arm 5

Placebo Comparator group

Treatment:

Drug: Vehicle

Drug: Vehicle

Drug: Vehicle

Arm 6

Placebo Comparator group

Treatment:

Drug: Vehicle

Drug: Vehicle

Drug: Vehicle