Health TrialsbyHealthPanel

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

ConditionsInflammationUveitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuan Dong Nguyen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Laquinimod eye drops

    Drug

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

Treatment groups

12 Participants
are divided into 5 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Stage 2 Comparison Group AExperimental treatment 1 intervention
Group E: Stage 2 Comparison Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
After 2 weeks of study drug administration
2

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.

Time frame
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.

Time frame
Baseline to end of Study at 22-30days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Quan Dong Nguyen

Lead sponsor

Stanford University

Sponsor institution

Global Ophthalmic Research Center (GORC)

Collaborator

Source ClinicalTrials.gov
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