RECRUITING

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

Conditions

Inflammation Uveitis Laquinimod eye drops Topical Immunomodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

Quick Facts

Study Start:2024-05-03

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06161415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older 2. Participants who are capable and willing to provide informed consent and follow study instructions. 3. Participants who are scheduled to undergo pars plana vitrectomy (PPV). 4. Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye 5. Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.	1. Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis). 2. Participants with active infectious uveitis 3. Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment 4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment. 5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment 6. Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery 7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study). 8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study) 9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C) 10. Moderate or severe renal impairment (GFR ≤60 mL/min) 11. History of HIV disease or other immunodeficiency disorder 12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C 13. History of organ or bone marrow transplant 14. Presence of malignancy under active treatment 15. Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study 16. Already enrolled in a clinical trial. 17. Any condition that would prevent the investigator from acquiring images of the eye as required per protocol

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older
2. Participants who are capable and willing to provide informed consent and follow study instructions.
3. Participants who are scheduled to undergo pars plana vitrectomy (PPV).
4. Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
5. Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.

1. Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
2. Participants with active infectious uveitis
3. Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
6. Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery
7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
10. Moderate or severe renal impairment (GFR ≤60 mL/min)
11. History of HIV disease or other immunodeficiency disorder
12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
13. History of organ or bone marrow transplant
14. Presence of malignancy under active treatment
15. Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study
16. Already enrolled in a clinical trial.
17. Any condition that would prevent the investigator from acquiring images of the eye as required per protocol

Contacts and Locations

Study Locations (Sites)

Spencer Center for Vision Research at the Byers Eye Institute

Palo Alto, California, 94303

United States

Collaborators and Investigators

Sponsor: Quan Dong Nguyen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

Uveitis
Inflammation
Laquinimod eye drops
Topical
Immunomodulation

Additional Relevant MeSH Terms

Inflammation
Uveitis