Official Title: “A Phase 1, Open-Label Study of Latanprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%”

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.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: latanoprost
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Plasma latanoprost acid concentrations at steady-state.
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Adverse events related to systemic exposure of latanoprost
  • Time Frame: 1 Day
    Safety Issue?: Yes

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 3 months of the screen visit.
• Use of continuous wear contact lenses.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638742

Study ID Number: A6111139

ClinicalTrials.gov Identifier: NCT00638742

Health Authority: United States: Food and Drug Administration

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