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

Last updated: May 12, 2025
Sponsor: Quan Dong Nguyen
Overall Status: Active - Recruiting

Phase

1

Condition

Uveitis

Inflammation

Treatment

Laquinimod eye drops

Clinical Study ID

NCT06161415
71341
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older

  2. Participants who are capable and willing to provide informed consent and followstudy instructions.

  3. Participants who are scheduled to undergo pars plana vitrectomy (PPV).

  4. Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye

  5. Women who are not pregnant or lactating, are post-menopausal or have undergone asterilization procedure.

Exclusion

Exclusion Criteria:

  1. Participants with active periocular or ocular infectious disease (e.g., blepharitis,scleritis, or conjunctivitis, keratitis or endophthalmitis).

  2. Participants with active infectious uveitis

  3. Participants with a history of prior intraocular or extraocular surgery within 90days of study enrollment

  4. Participant with a history of intravitreal steroids administered to the study eyewithin 90 days of enrollment.

  5. Participants with a history of intravitreal injection of VEGF inhibitors within 30days of enrollment

  6. 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

  7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2weeks of Baseline visit (and during the study).

  8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks ofBaseline visit (and during the study)

  9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)

  10. Moderate or severe renal impairment (GFR ≤60 mL/min)

  11. History of HIV disease or other immunodeficiency disorder

  12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C

  13. History of organ or bone marrow transplant

  14. Presence of malignancy under active treatment

  15. Any other acute or chronic medical condition that would, in the judgment of thestudy investigators, reasonably preclude participation in the clinical study

  16. Already enrolled in a clinical trial.

  17. Any condition that would prevent the investigator from acquiring images of the eyeas required per protocol

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Laquinimod eye drops
Phase: 1
Study Start date:
May 03, 2024
Estimated Completion Date:
July 31, 2025

Study Description

Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study. Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled.

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.

Connect with a study center

  • Spencer Center for Vision Research at the Byers Eye Institute

    Palo Alto, California 94303
    United States

    Active - Recruiting

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