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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Quan Dong Nguyen
Study ID
NCT06161415
Phase
PHASE1
Status
Recruiting
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Conditions

  • Inflammation
  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 3, 2024
Status verified
May 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Spencer Center for Vision Research at the Byers Eye InstitutePalo AltoCalifornia94303
LION Study Team
[email protected]
+1 650-723-6995

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By research site
Spencer Center for Vision Research at the Byers Eye Institute· Palo Alto, CA

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