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Dry Eye DiseasePhase 3NGL-Long TermNCT07111013

A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease

A Phase 3 study testing Lifitegrast/perfluorohexyloctane (PFHO) in people with Dry Eye Disease, run by Bausch & Lomb Incorporated.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
Lifitegrast/perfluorohexyloctane (PFHO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2025to Apr 2027
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • This study will include subjects who meet all of the following inclusion criteria:
  • Voluntarily provide written informed consent
  • Completed Study BL-RX01-OPUSNG-1201 and:
  • Were compliant with BL-RX01-OPUSNG-1201 trial procedures and study drug use
  • Had no important protocol deviations
  • Had no ongoing adverse events (AEs)
  • Are able and willing to follow instructions, including participation in all trial assessments and visits

Who cannot join

  • 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):
  • Have best-corrected visual acuity (BCVA) of 0.7 logMAR or worse (50 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening/Baseline)
  • Have any clinically significant (CS) ocular surface slit-lamp findings and/or in the opinion of the Investigator have any findings that may interfere with trial parameters
  • Any concurrent condition, concomitant treatment, or situation which, in the Investigator's opinion, may put the subject at significant risk, confound study results, or interfere with their participation in the trial
  • Planned contact lens use during the trial
  • Planned ocular and/or lid surgeries during the trial
Show all 22Show fewer
  • Unable or unwilling to avoid all topical dry eye treatments (except for study drug) during the first 4 weeks of participation
  • Any non-drug therapies affecting meibomian glands such as LipiFlow® and Intense Pulse Light during the trial
  • Participation in any investigational drug or device study other than BL RX01-OPUSNG-1201 or BL-RX01-NGL-1301-LTS
  • Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 1 (Screening/Baseline)
  • Any female of childbearing potential (FOCBP) who is unwilling to agree to:
  • Have a urine pregnancy testing performed at Visit 1 (Screening/Baseline)
  • Use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug, throughout the study duration, and for 1 month after the last dose of study drug Note: FOCBPs include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
  • Note: Acceptable forms of birth control include:
  • Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)
  • Hormonal contraceptive (oral, injectable, implantable, or transdermal)
  • Intrauterine device
  • Surgical sterilization of male partner at least 3 months prior to the first dose of study drug Note: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
  • Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP)
  • Note: Acceptable forms of birth control include:
  • True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or
  • Vasectomy at least 3 months prior to the first dose of study drug Without a vasectomy, must use condoms with spermicidal foam, gel, film, cream, suppository at least 14 days prior to the first dose of study drug, throughout the study duration, and for 1 month after the last dose of the study drug

About this study

Official title: A 12-Month, Multicenter, Open-Label Extension (OLE) Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease

A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease

Conditions
Dry Eye Disease
Being tested
Lifitegrast/perfluorohexyloctane (PFHO)
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifitegrast/perfluorohexyloctane (PFHO)Drug

    fixed-dose combination (FDC) (5%/95%)

Study groups in NCT07111013
Study groupRoleWhat they receive
Lifitegrast/perfluorohexyloctane (PFHO) fixed-dose combination (FDC) (5%/95%)ExperimentalLifitegrast/perfluorohexyloctane (PFHO) fixed-dose combination (FDC) (5%/95%) packaged in multidose bottles, with 1 topical ocular drop instilled in both eyes (OU) twice daily (BID)
Receives: Drug: Lifitegrast/perfluorohexyloctane (PFHO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Emergent Adverse Events

    Measured: Assessed for 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111013
Sponsor's protocol ID
BL-RX01-NGL-1301-LTS
Acronym
NGL-Long Term
Status last verified
Dec 2025
First submitted
6 Aug 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lifitegrast/perfluorohexyloctane (PFHO) in people with Dry Eye Disease, run by Bausch & Lomb Incorporated.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (time frame: Assessed for 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07111013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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