Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161415
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-11-29
Brief Title:
Safety Tolerability and Distribution of Laquinimod Eye Drops The LION Study
Sponsor:
Quan Dong Nguyen
Organization:
Stanford University
Study Overview
Official Title:
Safety Tolerability and Distribution of Topical Laquinimod Eye Drops an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor AhR The LION Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LION
Brief 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
Detailed Description:
Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled
The study will consist of two stages
Stage One - Open label dose escalation
Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor vitreous and plasma
Stage Two- Randomized Controlled Comparison of 2 Laquinimod doses
After the dose escalation cohorts are analysed 2 Laquinimod doses will be selected for a randomized comparison The doses in stage 2 will not exceed those studied in stage 1
The study will consist of two stages
Stage One - Open label dose escalation
Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor vitreous and plasma
Stage Two- Randomized Controlled Comparison of 2 Laquinimod doses
After the dose escalation cohorts are analysed 2 Laquinimod doses will be selected for a randomized comparison The doses in stage 2 will not exceed those studied in stage 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None