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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-001128-35-IT |
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Date of registration:
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07/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A 12-week randomized, evaluator-masked, parallel-group, multinational, multi-center study comparing the efficacy and safety of the fixed combination of latanoprost and timolol XalacomTM with the fixed combination of dorzolamide and timolol CosoptTM in subjects with open-angle glaucoma or ocular hypertension.
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Scientific title:
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A 12-week randomized, evaluator-masked, parallel-group, multinational, multi-center study comparing the efficacy and safety of the fixed combination of latanoprost and timolol XalacomTM with the fixed combination of dorzolamide and timolol CosoptTM in subjects with open-angle glaucoma or ocular hypertension. |
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Date of first enrolment:
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15/06/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001128-35 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Germany
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Italy
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
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:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Reduction of intraocular pressure IOP in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers.
MedDRA version: 6.1
Level: PT
Classification code 10030348
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Intervention(s)
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Trade Name: Xalacom
Pharmaceutical Form: Eye drops, solution
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Cosopt
Pharmaceutical Form: Eye drops, solution
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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2005-001128-35-DE
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A6641038
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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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