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

NCT06161415 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 71341
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Uveitis

Keywords

Uveitis; Inflammation; Laquinimod eye drops; Topical; Immunomodulation

Outcome Measures

Primary Outcomes (2)

• Concentration of Laquinimod in aqueous humor and vitreous samples of human participants

  Assessment of concentration of Laquinimod in aqueous humor and vitreous samples of human by biolanalysis in specialized lab participants on Day 14 of Laquinimod eye-drop administration.

  After 2 weeks of study drug administration

• Concentration of Laquinimod in plasma of human participants

  Assessment of concentration of Laquinimod in plasma of human participants on Day 14 of Laquinimod in specialized lab eye-drop administration. participants on Day 14 of Laquinimod eye-drop administration.

  After 2 weeks of study drug administration

Secondary Outcomes (1)

• Safety Assessment

  Baseline to end of Study at 22-30days

Study Arms (5)

Group 1

EXPERIMENTAL

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops once a day (0.6mg per day) in the study eye for 14 days before the surgery.

Drug: Laquinimod eye drops

Group 2

EXPERIMENTAL

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops twice a day (1.2mg per day) in the study eye for 14 days before the surgery

Drug: Laquinimod eye drops

Group 3

EXPERIMENTAL

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops three times a day(1.8 mg per day) for 14 days before the surgery.

Drug: Laquinimod eye drops

Stage 2 Comparison Group A

EXPERIMENTAL

(3 to 6 participants): Participants will receive a dose of Laquinimod eye drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.

Drug: Laquinimod eye drops

Stage 2 Comparison Group B

EXPERIMENTAL

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.

Drug: Laquinimod eye drops

Interventions

Laquinimod eye drops DRUG

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

Also known as: LAQ eye drops

Group 1; Group 2; Group 3; Stage 2 Comparison Group A; Stage 2 Comparison Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Participants who are capable and willing to provide informed consent and follow study instructions.
• Participants who are scheduled to undergo pars plana vitrectomy (PPV).
• Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
• Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.

You may not qualify if:

• Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
• Participants with active infectious uveitis
• Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
• Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
• Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
• Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery
• Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
• Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
• Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
• Moderate or severe renal impairment (GFR ≤60 mL/min)
• History of HIV disease or other immunodeficiency disorder
• History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
• History of organ or bone marrow transplant
• Presence of malignancy under active treatment
• Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study

Sponsors & Collaborators

• Quan Dong Nguyen: lead
• Global Ophthalmic Research Center (GORC): collaborator

Study Sites (1)

Spencer Center for Vision Research at the Byers Eye Institute

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Inflammation; Uveitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uveal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: The study will consist of two stages: Stage One - Open label dose escalation: Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor, vitreous and plasma. Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses: After the dose escalation cohorts are analysed, 2 Laquinimod doses will be selected for a randomized comparison. The doses in stage 2 will not exceed those studied in stage 1.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: May 3, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)