ocular side effects with ADCs
Conditions
Interventions
BYON5667 or placebo eye drops
Sponsors
Byondis B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male and female subjects, aged from 18 to 75 years at the time of signing informed consent. Presence of two functional eyes. Good physical and mental health. Female subjects of childbearing potential: an acceptable effective method of contraception must be used during the trial until the end-of-study (EOS ).
Exclusion criteria
Exclusion criteria: Presence or history of ocular disease or ocular trauma, or history of ocular surgery including laser-therapy, or ocular signs or symptoms of systemic disease , including current or prior pathology of eyelid or tear duct . Amblyopia and color blindness are allowed. Recent (within 2 months prior to signing informed consent) or current use of eye drops, or other (systemic) medication that may affect the eye according to the summary of product characteristics. Use of contact lenses within 14 days before Day 1 and for the duration of the study. Known active microbial, fungal or viral infection if deemed clinically significant by the investigator. Subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ophthalmological examinations (i.e. visual acuity, slit lamp exam, corneal sensitivity testing, and fluorescence tear film break-up time); Tolerability scores (Ocular Comfort Index (OCI) and Visual Analogue Scale (VAS)). | — |
Countries
Netherlands
Outcome results
None listed