Lifitegrast Eye Drops in Healthy SubjectsPhase I Study
Status:
COMPLETED
Trial end date:
2023-04-10
Target enrollment:
Participant gender:
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, z, and AUC\_%Extrap. The PK profiles between the two treatments will be compared to evaluate bioequivalence and assess the safety of Lifitegrast Ophthalmic Solution.