NCT06161415 Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
| NCT ID | NCT06161415 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Quan Dong Nguyen |
| Condition | Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-05-03 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older 2. Participants who are capable and willing to provide informed consent and follow study 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 a sterilization procedure. 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 90 days of study enrollment 4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment. 5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days 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 2 weeks of Baseline visit (and during the study). 8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline 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 the study 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 eye as required per protocol
Frequently Asked Questions
Who can join the NCT06161415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06161415 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06161415 currently recruiting?
Yes, NCT06161415 is actively recruiting participants. Visit ClinicalTrials.gov or contact Quan Dong Nguyen to inquire about joining.
Where is the NCT06161415 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06161415 clinical trial?
NCT06161415 is sponsored by Quan Dong Nguyen. The trial plans to enroll 12 participants.