Quan Dong Nguyen
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.
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. The study will consist of two stages: Stage One - 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. Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses: After the dose escalation cohorts are…
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. Participant…
n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned
Arctuva estimate
Verify or correct the compensation shown for this listing.