← Back to Search

Immunomodulator

Stage 2 Comparison Group A for Inflammation (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

LION Trial 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.Check my eligibility

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.See study design

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.

LION Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentration of Laquinimod in aqueous humor and vitreous samples of human participants

Concentration of Laquinimod in plasma of human participants

Secondary outcome measures

Safety Assessment

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391

Ocular hyperaemia

Eye pruritus

Nasopharyngitis

Dry eye

Acute tonsillitis

Pharyngitis

Conjunctivitis allergic

Eyelids pruritus

Blepharal pigmentation

Eye irritation

Cataract

Arthritis

Hypersensitivity

Eye pain

Ocular surface disease

100%

80%

60%

40%

20%

Study treatment Arm

DuoTrav

Beta-blocker

LION 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.

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of participants being recruited for this clinical investigation?

"Indeed, clinicaltrials.gov data affirms that this research endeavor is actively pursuing eligible candidates. The trial was initially disclosed on March 1st, 2024 and the most recent update occurred on March 27th, 2024. This investigation aims to recruit a total of 12 participants from one designated site."

Answered by AI

Has Group 1 received official endorsement from the FDA?

"Based on our evaluation at Power, Group 1's safety rating is a 1 due to the preliminary nature of this Phase I trial, indicating minimal supporting data for both efficacy and safety."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"The clinical trial, actively seeking participants as documented on clinicaltrials.gov, was initially published on March 1st, 2024 and last revised on March 27th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

Quan Dong Nguyen 2024. "Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161415.

All > Uveitis