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

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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07111013
Acronym
NGL-Long Term
Enrollment
0
Registered
2025-08-08
Start date
2025-12-31
Completion date
2027-04-30
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

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

Interventions

DRUGLifitegrast/perfluorohexyloctane (PFHO)

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

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

This study will include subjects who meet all of the following inclusion criteria: 1. Voluntarily provide written informed consent 2. Completed Study BL-RX01-OPUSNG-1201 and: 1. Were compliant with BL-RX01-OPUSNG-1201 trial procedures and study drug use 2. Had no important protocol deviations 3. Had no ongoing adverse events (AEs) 3. Are 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

Design outcomes

Primary

MeasureTime frame
Incidence of Treatment Emergent Adverse EventsAssessed for 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026