RecruitingPhase 1NCT06161415

Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study


Sponsor

Quan Dong Nguyen

Enrollment

12 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The LION Study is a Phase 1 clinical trial testing the safety, tolerability, and distribution of laquinimod — an anti-inflammatory drug — when applied as eye drops in adults scheduled for vitrectomy eye surgery. Researchers want to know how much of the drug reaches different parts of the eye and whether it is safe for topical ophthalmic use, with the long-term goal of treating inflammatory eye conditions. Eligible participants are adults aged 18 or older who are already scheduled for vitrectomy, have stable eye pressure, and are not pregnant, not infected, and do not have significant liver or kidney impairment. Participation involves applying laquinimod eye drops for 2 weeks before surgery, with the drug measured in eye fluid and blood samples collected during the procedure. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLaquinimod eye drops

n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned


Locations(1)

Spencer Center for Vision Research at the Byers Eye Institute

Palo Alto, California, United States

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NCT06161415


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