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

Inflammation Clinical Trial

— LION  

Official title:

Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161415
• Other study ID #: 71341
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Uveitis

Intervention

Drug:
• Laquinimod eye drops
n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned

Locations

Country	Name	City	State
United States	Spencer Center for Vision Research at the Byers Eye Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Quan Dong Nguyen	Global Ophthalmic Research Center (GORC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Laquinimod in aqueous humor and vitreous samples of human participants	Assessment of concentration of Laquinimod in aqueous humor and vitreous samples of human by biolanalysis in specialized lab participants on Day 14 of Laquinimod eye-drop administration.	After 2 weeks of study drug administration
Primary	Concentration of Laquinimod in plasma of human participants	Assessment of concentration of Laquinimod in plasma of human participants on Day 14 of Laquinimod in specialized lab eye-drop administration. participants on Day 14 of Laquinimod eye-drop administration.	After 2 weeks of study drug administration
Secondary	Safety Assessment	Any Adverse events: ocular and non-ocular at Post operative Day 1 and Post operative Day 8 compared to baseline.	Baseline to end of Study at 22-30days