Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.
Locations
United States
California
Spencer Center for Vision Research at the Byers Eye Institute
RECRUITING
Palo Alto
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2025-07
Participants
Target number of participants: 12
Treatments
Experimental: Group 1
(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.
Experimental: Group 2
(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
Experimental: Group 3
(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.
Experimental: Stage 2 Comparison Group A
(3 to 6 participants): Participants will receive a dose of Laquinimod eye drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.
Experimental: Stage 2 Comparison Group B
(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.
Related Therapeutic Areas
Sponsors
Leads: Quan Dong Nguyen
Collaborators: Global Ophthalmic Research Center (GORC)