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

Launched by QUAN DONG NGUYEN · Nov 29, 2023

Keywords

ClinConnect Summary

The LION Study is a clinical trial that is looking at the safety and effects of a new eye drop medication called Laquinimod, which is being tested for its ability to treat inflammation in the eye, specifically a condition called uveitis. This study is open to adults aged 18 and older who are scheduled for a specific eye surgery called pars plana vitrectomy. To join, participants need to be able to understand the study and give their consent, and they must have a certain range of eye pressure.

If you or a family member are considering participation, you should know that the study will involve using the eye drops for two weeks before the surgery. Participants will be closely monitored for any side effects and how well the drops spread in the eye. However, there are some health conditions that would prevent someone from joining the study, including active eye infections or recent surgeries. Overall, the LION Study aims to gather important information that could help improve treatments for eye inflammation in the future.

Gender

ALL

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