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Immunomodulator
Laquinimod Eye Drops for Uveitis (LION Trial)
Phase 1
Recruiting
Research Sponsored by Quan Dong Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study at 22-30days
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing the safety and effectiveness of using eye drops containing Laquinimod in humans for two weeks."
Who is the study for?
The LION Study is for adults over 18 who can follow study instructions and consent to participate. It's suitable for non-pregnant, non-lactating women who are post-menopausal or sterilized. Participants must be scheduled for specific eye surgeries (PPV or diagnostic vitrectomy) and have normal intraocular pressure.
What is being tested?
This trial tests Laquinimod eye drops' safety and how well they're tolerated when used daily for two weeks. Researchers also want to see how the drug spreads in the eyes of participants undergoing certain eye surgeries.
What are the potential side effects?
Since this is a phase 1 trial primarily focused on safety, detailed side effects aren't listed but may include irritation at the application site, changes in vision, discomfort, redness, or other reactions related to the eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of study at 22-30days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study at 22-30days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Concentration of Laquinimod in aqueous humor and vitreous samples of human participants
Concentration of Laquinimod in plasma of human participants
Secondary study objectives
Safety Assessment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Stage 2 Comparison Group BExperimental Treatment1 Intervention
(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.
Group II: Stage 2 Comparison Group AExperimental Treatment1 Intervention
(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.
Group III: Group 3Experimental Treatment1 Intervention
(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.
Group IV: Group 2Experimental Treatment1 Intervention
(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 V: Group 1Experimental Treatment1 Intervention
(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.
Find a Location
Who is running the clinical trial?
Global Ophthalmic Research Center (GORC)UNKNOWN
1 Previous Clinical Trials
24 Total Patients Enrolled
Quan Dong NguyenLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled