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

Verified by: Pfizer, December 2010
First Received: March 12, 2008 | Last Updated: December 29, 2010 | Phase: Phase 1 | Start Date: May 2008
Overall Status: Completed | Estimated Enrollment: 47
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
  • Study Primary Completion Date: March 2009

Detailed Clinical Trial Description

Pharmacokinetics and Safety

Intervention(s) in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Plasma latanoprost acid concentrations at steady-state.
    • Time Frame: 2 weeks
      Safety Issue?: No

Secondary Measures

  • Adverse events related to systemic exposure of latanoprost
    • Time Frame: 1 Day
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638742

Study ID Number: A6111139

ClinicalTrials.gov Identifier: NCT00638742

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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