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Completed

NCT Number: NCT07128628

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

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye Doctors of Arizona, PLLC, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Drug

Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks

Lifitegrast

Drug

Topical ocular drop of lifitegrast administered for 4 weeks

Perfluorohexyloctane

Drug

Topical ocular drop of perfluorohexyloctane administered for 4 weeks

Vehicle

Drug

Topical ocular drop with no active ingredients administered for 4 weeks

Primary outcomes

  1. Total corneal fluorescein staining change from baseline

    Time frame: Baseline, day 29

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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