Actively Recruiting
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
Led by Quan Dong Nguyen · Updated on 2025-05-14
12
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
Q
Quan Dong Nguyen
Lead Sponsor
G
Global Ophthalmic Research Center (GORC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to give informed consent and follow study instructions
- Scheduled to undergo pars plana vitrectomy (PPV) or diagnostic vitrectomy
- Intraocular pressure between 5 mmHg and 22 mmHg in the study eye
- Women who are not pregnant or lactating, or are post-menopausal or sterilized
You will not qualify if you...
- Active periocular or ocular infectious disease such as blepharitis, scleritis, conjunctivitis, keratitis, or endophthalmitis
- Active infectious uveitis
- Intraocular or extraocular surgery within 90 days prior to enrollment
- Intravitreal steroids in the study eye within 90 days prior to enrollment
- Intravitreal VEGF inhibitor injections within 30 days prior to enrollment
- Use of topical cyclosporine, corticosteroids, or calcineurin inhibitors in the study eye within 14 days prior to enrollment
- Use of strong or moderate CYP3A4 inhibitors or inducers within 2 weeks before baseline visit and during the study
- Any degree of hepatic impairment (Child-Pugh A, B, or C)
- Moderate or severe renal impairment (GFR ≤60 mL/min)
- History of HIV or other immunodeficiency disorders
- History of acute hepatitis A, B, or C
- History of organ or bone marrow transplant
- Active malignancy under treatment
- Any acute or chronic medical condition that could prevent safe participation
- Currently enrolled in another clinical trial
- Any condition preventing acquisition of required eye images
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Spencer Center for Vision Research at the Byers Eye Institute
Palo Alto, California, United States, 94303
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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