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

NCT ID: NCT07128628

Last Updated: 2025-11-12

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

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

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Study Manager Bausch and Lomb

Role: CONTACT

Phone: 2147262850

Email: [email protected]

Other Identifiers

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BL-RX01-OPUSNG-1201

Identifier Type: -

Identifier Source: org_study_id