Healthy Volunteers
Conditions
Brief summary
This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.
Interventions
eyedrops
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent signed and dated * Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study * Participants with no ocular symptoms
Exclusion criteria
* History of ocular trauma, infection, or inflammation within the last 3 months * Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation * IOP \<10 mmHg or \>21 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL) | at 2 timepoint : Baseline and week 2 |
| Ocular and systemic adverse events | up to week 2 |
Countries
United States
Outcome results
None listed