NCT06161415 · Quan Dong Nguyen
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
(LION)
What this study is about
The LION Study is a forward-looking, 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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Already enrolled in a clinical trial.
- Any condition that would prevent the investigator from acquiring images of the eye as required per protocol
Where
- Palo Alto, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2025 · Source of record for eligibility and locations