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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2008-000844-15-GR |
Date of registration:
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30/01/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
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Scientific title:
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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:
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18/12/2008 |
Target sample size:
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30 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000844-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Denmark
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Greece
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Italy
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Portugal
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Spain
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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GLAUCOMA MedDRA version: 9.1
Level: LLT
Classification code 10018304
Term: Glaucoma
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Intervention(s)
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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-
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Primary Outcome(s)
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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.
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Primary end point(s): • Plasma latanoprost acid concentrations at steady-state. • Adverse events related to systemic exposure of latanoprost.
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Secondary Objective: To assess the safety and tolerability of latanoprost 0.005% in pediatric subjects.
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Secondary ID(s)
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2008-000844-15-ES
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A6111139
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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