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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study at 22-30days for reporting.

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.

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