Recruiting
Phase 1

Laquinimod

Sponsor:

Quan Dong Nguyen

Code:

NCT06161415

Conditions

Inflammation

Uveitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laquinimod eye drops

Study Details

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.

Conditions

Inflammation

Uveitis

Study ID

NCT06161415

Start date

May 3, 2024

Status verified date

May, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops once a day (0.6mg per day) in the study eye for 14 days before the surgery.

experimental: Group 2

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops twice a day (1.2mg per day) in the study eye for 14 days before the surgery

experimental: Group 3

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops three times a day(1.8 mg per day) for 14 days before the surgery.

experimental: Stage 2 Comparison Group A

(3 to 6 participants): Participants will receive a dose of Laquinimod eye drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.

experimental: Stage 2 Comparison Group B

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.

Interventions

Laquinimod eye drops

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

Primary outcome measure

  • Concentration of Laquinimod in aqueous humor and vitreous samples of human participants [ Time Frame: After 2 weeks of study drug administration ]
  • Concentration of Laquinimod in plasma of human participants [ Time Frame: After 2 weeks of study drug administration ]

Central Contacts and Locations

Locations

Spencer Center for Vision Research at the Byers Eye Institute

Recruiting

Palo Alto, California, United States, 94303

Contacts

More Information

Sponsor

Quan Dong Nguyen

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Uveitis
  • Inflammation
  • Laquinimod eye drops
  • Topical
  • Immunomodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Quan Dong Nguyen on 2025-05-14.