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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00759239 |
The purpose of this study is to assess the IOP-lowering efficacy of a combination of Travoprost / Timolol maleate, dosed in the morning or in the evening, in patients with open-angle glaucoma or ocular hypertension, who have an insufficiently controlled IOP (mmHg), and are using prostaglandin analogue monotherapy.
Condition | Intervention | Phase |
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Open-Angle Glaucoma Ocular Hypertension |
Drug: Travoprost 0.004% / Timolol maleate 0.5% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Estimated Enrollment: | 70 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 am and 1 drop of Timolol vehicle as placebo in each eye at 9 pm for 12 weeks.
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Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, morning dosing
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2: Experimental
One drop of Timolol vehicle as placebo in each eye at 9 am and one drop of Travoprost 0.004% / Timolol maleate 0.5% in each eye at 9 pm for 12 weeks.
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Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, evening dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Meet the following IOP entry criteria in at least one treated eye (mean IOP):
Exclusion:
Females of childbearing potential (i.e. - those who are not surgically sterilised at least three months prior to the study start, or are not at least one year post-menopausal), who are:
Less than 30 days stable dosing regimen before the Screening Visit of any non-glaucoma medications or substances administered by any route and used on a chronic basis that may affect IOP. These may include, but are not limited to the following:
Responsible Party: | Alcon ( Anna Grau ) |
Study ID Numbers: | EMD-06-02 |
Study First Received: | September 24, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00759239 History of Changes |
Health Authority: | United Kingdom: Department of Health; United States: Food and Drug Administration |
Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension |
Neurotransmitter Agents Adrenergic Agents Eye Diseases Vascular Diseases Cardiovascular Agents Antihypertensive Agents Travoprost Glaucoma |
Glaucoma, Open-Angle Adrenergic beta-Antagonists Adrenergic Antagonists Timolol Anti-Arrhythmia Agents Ocular Hypertension Hypertension |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Eye Diseases Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Travoprost |
Glaucoma Therapeutic Uses Glaucoma, Open-Angle Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Hypertension Ocular Hypertension |