A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000844-15-PT
• Date of registration: 09/05/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US
• Public title: A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
• Scientific title: A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
• Date of first enrolment: 11/07/2008
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000844-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Denmark, Greece, Italy, Portugal, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
• male or female subjects of any age with glaucoma or ocular hypertension, receiving treatment with latanoprost 0.005% in one or both eyes for a minimum of 2 weeks.
• evidence of signed and dated an informed consent document indicating that the subject or the subject’s parent (or legal guardian) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws and regulations.
• willing and able to comply with schedule visits, treatment plan, and other study procedures (subject and for minors, parent/legal guardian).
• females of childbearing potential (post menarchal females) must have a negative urine pregnancy test at screening or on the study day (prior to dosing).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 3 months of the screen visit.
• history of hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients contained in Xalatan.
• use of continuous wear contact lenses.
• pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the dose of study medication until 28 days after dosing.
• evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• history of febrile illness within 5 days prior to the start of the study.
• other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• treatment with an investigational drug within 30 days or 5 half-lives preceding the first day of study.
• history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

GLAUCOMA
MedDRA version: 9.1 Level: LLT Classification code 10018304 Term: Glaucoma

Intervention(s)

Trade Name: Xalatan- 0.005% w/v eye drops solution

Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: latanoprost
CAS Number: 130209-82-4
Other descriptive name: latanoprost 0.005% ophthalmic solution
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.005-

Primary Outcome(s)

Secondary Objective: To assess the safety and tolerability of latanoprost 0.005% in pediatric subjects.

Main Objective: To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 µg) in pediatric and adult subjects with glaucoma or ocular hypertension.

Primary end point(s): • Plasma latanoprost acid concentrations at steady-state.
• Adverse events related to systemic exposure of latanoprost.

Secondary ID(s)

2008-000844-15-ES

A6111139