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NCT00638742 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00638742
Other study ID # A6111139
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2008
Est. completion date March 2009

Study information
Verified date December 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Pharmacokinetics and Safety

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Pfizer Investigational Site Koebenhavn OE
Italy Pfizer Investigational Site Catania
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Lisboa
South Africa Pfizer Investigational Site Mayfair West
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
United States Pfizer Investigational Site Artesia California
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site North Dartmouth Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Denmark,  Italy,  Portugal,  South Africa,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma latanoprost acid concentrations at steady-state. 2 weeks
Secondary Adverse events related to systemic exposure of latanoprost 1 Day
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