Glaucoma, Ocular Hypertension
Conditions
Brief summary
The study purpose is to evaluate the safety of T4090.
Interventions
DRUGKinezodianone R hydrochloride
Eyedrops
DRUGPlacebo
Placebo
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent dated and signed. * Both eyes diagnosed open-angle glaucoma or ocular hypertension
Exclusion criteria
* History of trauma, infection, clinically significant inflammation within the previous 6 months * Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular and systemic adverse events | up to 22 days | Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation. |
Countries
United States
Outcome results
None listed