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Lifitegrast Eye Drops in Healthy Subjects：Phase I Study

NCT07040826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-27

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, single-dose, two-period crossover Phase I clinical trial designed to:

* Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears following single-dose administration in healthy subjects.
* Evaluate the safety and tolerability of Lifitegrast Ophthalmic Solution in healthy subjects.

A total of 24 healthy subjects will be randomized into two treatment sequences (Group A: T/R; Group B: R/T). The study duration per subject will be approximately 36 days, including:

* Screening Period (Day -21 to Day -1)
* Treatment Periods (Day 1, followed by a 7-day washout period, then Day 8 or early termination)
* Safety Follow-up (Day 15, 7 days after the last dose).

On Day 1 of Cycle 1, one study eye will be selected and designated for all subsequent tear PK sampling. Treatment assignments:

* Group A: Lifitegrast (T) on Day 1, then Xiidra® (R) on Day 8.
* Group B: Xiidra® (R) on Day 1, then Lifitegrast (T) on Day 8. Each subject will receive one drop of the assigned medication (either Lifitegrast or Xiidra®) in each eye from the same single-dose container. Blood and tear samples will be collected per protocol for PK analysis, including parameters such as Cmax, AUC0-∞, AUC0-t, Tmax, T1/2, λz, and AUC\_%Extrap. The PK profiles between the two treatments will be compared to evaluate bioequivalence and assess the safety of Lifitegrast Ophthalmic Solution.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Xiidra

Administered on Day 1 to subjects in Group B, and on Day 8 to subjects in Group A as part of a crossover study design.

DRUG

Lifitegrast

Administered on Day 1 to subjects in Group A, and on Day 8 to subjects in Group B as part of a crossover study design.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2022-12-19
Completion
2023-04-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040826 on ClinicalTrials.gov