Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
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
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
Treatments tested in this trial
- Laquinimod eye drops
Treatment groups
12 Participants
are divided into 5 treatment groupsSponsors and collaborators
Quan Dong Nguyen
Lead sponsor
Stanford University
Sponsor institution
Global Ophthalmic Research Center (GORC)
Collaborator
Source ClinicalTrials.gov