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

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ClinicalTrials.gov Identifier: NCT00638742
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : December 31, 2010
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: latanoprost Phase 1

Detailed Description:
Pharmacokinetics and Safety

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%.
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: 1 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.




Primary Outcome Measures :
  1. Plasma latanoprost acid concentrations at steady-state. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Adverse events related to systemic exposure of latanoprost [ Time Frame: 1 Day ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Coimbra, Portugal, 3000-548
Pfizer Investigational Site
Lisboa, Portugal, 1169-097
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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00638742     History of Changes
Other Study ID Numbers: A6111139
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: December 31, 2010
Last Verified: December 2010

Keywords provided by Pfizer:
Latanoprost Pediatrics Pharmacokinetics Safety

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents