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

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Phase 1, Open-Label Study of Latanoprost 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetics and Safety

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma latanoprost acid concentrations at steady-state.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events related to systemic exposure of latanoprost
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6111139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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