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OpenTrials
Completed

NCT Number: NCT00638742

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Koebenhavn OE, Denmark

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About this study

Pharmacokinetics and Safety

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

latanoprost

Drug

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 outcomes

  1. Plasma latanoprost acid concentrations at steady-state.

    Time frame: 2 weeks

Secondary outcomes

  1. Adverse events related to systemic exposure of latanoprost

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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