NCT07040826

Lifitegrast Eye Drops in Healthy Subjects：Phase I Study

Pharmacokinetics and Safety Study of Lifitegrast Eye Drops in Healthy Subjects - A Single-Center, Randomized, Double-Blind, Single-Dose, Two-Period Crossover Design Phase I Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-12-06
• Primary completion: 2022-12-19
• Completion: 2023-04-10
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: China