InflammationPhase 1LIONNCT06161415
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
A Phase 1 study testing Laquinimod eye drops in people with Inflammation and Uveitis, run by Quan Dong Nguyen at 1 site in United States.
Trial summary
The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Uveitis
- What is being tested?
- Laquinimod eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Participants who are capable and willing to provide informed consent and follow study instructions.
- Participants who are scheduled to undergo pars plana vitrectomy (PPV).
- Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
- Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.
Who cannot join
- Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
- Participants with active infectious uveitis
- Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
- Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
- Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
- 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
Show all 17Show fewer
- Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
- Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
- Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
- Moderate or severe renal impairment (GFR ≤60 mL/min)
- History of HIV disease or other immunodeficiency disorder
- History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
- History of organ or bone marrow transplant
- Presence of malignancy under active treatment
- Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study
- Already enrolled in a clinical trial.
- Any condition that would prevent the investigator from acquiring images of the eye as required per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
About this study
Official title: Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study
The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.
Read the detailed 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.
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.
- Conditions
- Inflammation, Uveitis
- Being tested
- Laquinimod eye drops
- Keywords
- Uveitis, Inflammation, Laquinimod eye drops, Topical, Immunomodulation
- Medical subject headings
- Inflammation, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laquinimod eye dropsDrug
Also called LAQ eye drops
n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | (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. Receives: Drug: Laquinimod eye drops |
| Group 2 | Experimental | (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 Receives: Drug: Laquinimod eye drops |
| Group 3 | Experimental | (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. Receives: Drug: Laquinimod eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 weeks of study drug administration
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.
Measured: After 2 weeks of study drug administration
Secondary outcomes (1)
Safety Assessment
Any Adverse events: ocular and non-ocular at Post operative Day 1 and Post operative Day 8 compared to baseline.
Measured: Baseline to end of Study at 22-30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start3 May 2024
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quan Dong Nguyen
- Sponsor type
- University, hospital or other
- Collaborators
- Global Ophthalmic Research Center (GORC)
- Responsible party
- Sponsor-investigator, Quan Dong Nguyen, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161415
- Sponsor's protocol ID
- 71341
- Acronym
- LION
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
El Feky D, Akhavanrezayat A, Mobasserian A, Khan H, Elaraby O, Yavari N, Halim MS, Tram Tran AN, Khatri A, Kirimli GU, Tuong Than NT, Vahtola E, Torngren M, Hung JH, Moussa M, DeBoer C, Mruthyunjaya P, Smith S, Or C, Kabeel M, Serag Y, Do DV, Urtti A, Nguyen QD. Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study. Ophthalmol Sci. 2026 Apr 3;6(6):101186. doi: 10.1016/j.xops.2026.101186. eCollection 2026 Jun.
PubMed 42211725
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study
- ClinicalTrials.gov ID
- NCT06161415
- Acronym / sponsor ID
- LION / 71341
- Conditions
- Inflammation, Uveitis
- Keywords
- Uveitis, Inflammation, Laquinimod eye drops, Topical, Immunomodulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Quan Dong NguyenUniversity, hospital or other
- Collaborators
- Global Ophthalmic Research Center (GORC)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.
Detailed 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Laquinimod eye drops(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. |
| Group 2 | Experimental | Drug: Laquinimod eye drops(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 |
| Group 3 | Experimental | Drug: Laquinimod eye drops(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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Participants who are capable and willing to provide informed consent and follow study instructions.
- Participants who are scheduled to undergo pars plana vitrectomy (PPV).
- Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
- Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.
Key exclusion criteria (17 listed)
- Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
- Participants with active infectious uveitis
- Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
- Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
- Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laquinimod eye dropsAlso: LAQ eye dropsn Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Concentration of Laquinimod in aqueous humor and vitreous samples of human participants
Time frame: After 2 weeks of study drug administration
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.
Concentration of Laquinimod in plasma of human participants
Time frame: After 2 weeks of study drug administration
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.
1 secondary outcome
Safety Assessment
Time frame: Baseline to end of Study at 22-30days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 42211725El Feky D, Akhavanrezayat A, Mobasserian A, Khan H, Elaraby O, Yavari N, Halim MS, Tram Tran AN, Khatri A, Kirimli GU, Tuong Than NT, Vahtola E, Torngren M, Hung JH, Moussa M, DeBoer C, Mruthyunjaya P, Smith S, Or C, Kabeel M, Serag Y, Do DV, Urtti A, Nguyen QD. Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study. Ophthalmol Sci. 2026 Apr 3;6(6):101186. doi: 10.1016/j.xops.2026.101186. eCollection 2026 Jun.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laquinimod eye drops in people with Inflammation and Uveitis, run by Quan Dong Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Laquinimod in aqueous humor and vitreous samples of human participants (time frame: After 2 weeks of study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06161415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.