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| Sponsor: | Alcon Research |
|---|---|
| Information provided by (Responsible Party): | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00759239 |
Purpose
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 |
|---|---|---|
|
Open-angle Glaucoma Ocular Hypertension |
Drug: Travoprost 0.004% / Timolol maleate 0.5% |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Enrollment: | 36 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, morning dosing
|
|
Experimental: 2
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.
|
Drug: Travoprost 0.004% / Timolol maleate 0.5%
Solution, evening dosing
|
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00759239 History of Changes |
| Other Study ID Numbers: | EMD-06-02 |
| Study First Received: | September 24, 2008 |
| Last Updated: | January 12, 2012 |
| 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 |
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Travoprost Maleic acid Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors |