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

NCT00638742 | Completed Phase 1

• 1 other identifier: A6111139
• Study Type: interventional
• Target: 47
• Locations: 6 countries
• Sites: 13

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Latanoprost Pediatrics Pharmacokinetics Safety

Outcome Measures

Primary Outcomes (1)

• Plasma latanoprost acid concentrations at steady-state.

  2 weeks

Secondary Outcomes (1)

• Adverse events related to systemic exposure of latanoprost

  1 Day

Study Arms (1)

1

EXPERIMENTAL

Drug: latanoprost

Interventions

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.

1

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (13)

Pfizer Investigational Site

Artesia, California, 90701, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30339, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27705, United States

Location

Pfizer Investigational Site

Koebenhavn OE, 2100, Denmark

Location

Pfizer Investigational Site

Catania, 95123, Italy

Location

Pfizer Investigational Site

Coimbra, 3000-548, Portugal

Location

Pfizer Investigational Site

Lisbon, 1169-097, Portugal

Location

Pfizer Investigational Site

Mayfair West, 2109, South Africa

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Madrid, 28046, Spain

Location

Related Links

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

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 2, 2021

Record last verified: 2010-12

Locations

IT (1); ZA (1); DK (1); US (6); ES (2); PT (2)