Eye Diseases Clinical Trial
Official title:
A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops
Verified date | January 2023 |
Source | Active Biotech AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.
Status | Completed |
Enrollment | 54 |
Est. completion date | January 19, 2023 |
Est. primary completion date | January 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility | Main inclusion criteria: - In good health according to medical history, physical examination, vital signs, ECG and clinical chemistry, urinary and hematological laboratory tests Main exclusion criteria: - Unable or unwilling to use eye-drops - Current usage of contact lenses - History of eye surgery - Sign or symptom of active eye disease - History of an eye disease or other condition that could interfere with eye examinations in the study, or with ocular absorption of the investigational product - History of inflammatory ocular disease - History of cardiovascular or pulmonary disorder - Family history of known or suspected hereditary cardiovascular disease - Autoimmune disease or known family history of autoimmune disease - Any other condition that would contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures |
Country | Name | City | State |
---|---|---|---|
Austria | Clinical trial center at Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Active Biotech AB |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Type, frequency, seriousness, severity and relationship to treatment | For 7 days post-dose | |
Secondary | Participant-reported eye-toxicities | Assessed from change from baseline in ocular symptoms score determined using a Visual Analogue Scale with 0-100 range, where 0= no symptom and 100= worst possible discomfort. | Pre-dose (baseline) and immediately after the intervention | |
Secondary | Investigator-reported eye-toxicities - BCVA | Assessed from change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study research group (ETDRS) visual acuity chart with objective and subjective refraction. | Pre-dose (baseline) and immediately after the intervention | |
Secondary | Investigator-reported eye-toxicities - Slit lamp examination | Assessed from change from baseline in slit lamp examination parameters (eyelid swelling, eyelid redness, conjunctival redness, conjunctival chemosis, scleral redness, corneal opacity, iris alterations and anterior chamber flare) graded on a 4-point scale where 0= none, 1= mild, 2= moderate, and 3= severe. | Pre-dose (baseline) and immediately after the intervention | |
Secondary | Investigator-reported eye-toxicities - Corneal fluorescein staining | Assessed from change from baseline in corneal fluorescein staining determined using the NEI/Industry Workshop guidelines. The cornea is divided into five sectors (central, superior, inferior, nasal and temporal) and each sector scored on a 4-point scale, where 0= no staining and 3= maximum staining. | At screening visit (baseline) and immediately after the intervention | |
Secondary | Investigator-reported eye-toxicities - Intraocular pressure | Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer. | At screening visit (baseline) and immediately after the intervention | |
Secondary | Investigator-reported eye-toxicities - Funduscopy in mydriasis | Assessed from change from baseline in clinical signs detected by indirect funduscopic inspection of the optic disc, macula, retinal vessels and retinal periphery. | At screening visit (baseline) and immediately after the intervention | |
Secondary | Peak plasma concentration of laquinimod | Maximal plasma concentration (Cmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose | Over up to 21 days after (last) dose | |
Secondary | Time to peak plasma concentration of laquinimod | Time to maximal plasma concentration (tmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose | Over up to 21 days) after (last) dose | |
Secondary | Trough plasma concentration of laquinimod at steady-state | Minimal plasma concentration (Cmin,ss) of laquinimod as assessed from samples collected pre-dose on Days 12, 13 and 14 within the multiple-dose arm | On the last three days of multiple dosing | |
Secondary | Systemic exposure of laquinimod | Area under the plasma concentration time curve (AUC) of laquinimod | Over up to 21 days after (last) dose |
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