Glaucoma, Ocular Hypertension
Conditions
Keywords
Latanoprost Pediatrics Pharmacokinetics Safety
Brief summary
To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.
Detailed description
Pharmacokinetics and Safety
Interventions
DRUGlatanoprost
latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks. * The pediatric subjects will be grouped by age (0 to \<3 years, 3 to \<12 years, 12 to 18 years).
Exclusion criteria
* Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit. * History of ocular trauma or surgery in either eye within 14-days of the screening visit. * Use of continuous wear contact lenses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma latanoprost acid concentrations at steady-state. | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events related to systemic exposure of latanoprost | 1 Day |
Countries
Denmark, Italy, Portugal, South Africa, Spain, United States
Outcome results
None listed