Status:
COMPLETED
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
Phase:
PHASE1
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 hyperten...
Detailed Description
Pharmacokinetics and Safety
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00638742
Start Date
May 1 2008
End Date
March 1 2009
Last Update
February 2 2021
Active Locations (13)
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1
Pfizer Investigational Site
Artesia, California, United States, 90701
2
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
3
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
4
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747