A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

This study has been completed.

First Received: March 12, 2008 Last Updated: May 10, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00638742

Purpose

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.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: latanoprost	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Plasma latanoprost acid concentrations at steady-state. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events related to systemic exposure of latanoprost [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638742

Locations

United States, California
Pfizer Investigational Site
Artesia, California, United States, 90701
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
Denmark
Pfizer Investigational Site
Koebenhavn OE, Denmark, 2100
Italy
Pfizer Investigational Site
Catania, Italy, 95123
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1169-097
Pfizer Investigational Site
Coimbra, Portugal, 3000-548
South Africa
Pfizer Investigational Site
Mayfair West, South Africa, 2109
Spain
Pfizer Investigational Site
MADRID, Spain, 28040
Pfizer Investigational Site
MADRID, Spain, 28046

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6111139
Study First Received:	March 12, 2008
Last Updated:	May 10, 2009
ClinicalTrials.gov Identifier:	NCT00638742 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Latanoprost Pediatrics Pharmacokinetics Safety

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009