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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quan Dong Nguyen
• Collaborator: Global Ophthalmic Research Center (GORC)
• Treatments: Ophthalmic Solutions

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