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

NCT07111013 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: BL-RX01-NGL-1301-LTS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Assessed for 12 months

Study Arms (1)

Lifitegrast/perfluorohexyloctane (PFHO) fixed-dose combination (FDC) (5%/95%)

EXPERIMENTAL

Lifitegrast/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)

Drug: Lifitegrast/perfluorohexyloctane (PFHO)

Interventions

Lifitegrast/perfluorohexyloctane (PFHO) DRUG

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

Lifitegrast/perfluorohexyloctane (PFHO) fixed-dose combination (FDC) (5%/95%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast; perfluorohexyl-octan

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12