NCT07128628 · Bausch & Lomb Incorporated
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
What this study is about
A 4-Week, randomly assigned, Double-Masked, Parallel-Group, Active-Controlled, conducted at multiple hospitals Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Glendale, California
- Long Beach, California
- Murrieta, California
- Newport Beach, California
- Torrance, California
- Delray Beach, Florida
- Jacksonville, Florida
- Largo, Florida
- Morrow, Georgia
- Carmel, Indiana
- Pittsburg, Kansas
And 18 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations