Glaucoma Adherence Study (GAS)
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00676637
First received: May 12, 2008
Last updated: May 29, 2012
Last verified: May 2012
Tracking Information | |||||
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First Received Date ICMJE | May 12, 2008 | ||||
Last Updated Date | May 29, 2012 | ||||
Start Date ICMJE | May 2008 | ||||
Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mean Change from Baseline in Intraocular Pressure at 4 months [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ] As measured by Goldmann applanation tonometry |
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Original Primary Outcome Measures ICMJE |
General compliance measures for once daily dosing with Travalert [ Time Frame: On visit ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00676637 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Glaucoma Adherence Study | ||||
Official Title ICMJE | A Pilot Study of Adherence Assessment With the Travalert™ Dosing Aid in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Who Are Treated With the Travoprost/Timolol Maleate Fixed Combination Every Evening | ||||
Brief Summary | The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid. |
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Detailed Description | This study was conducted in France, UK, Italy, and Netherlands. An identical study was conducted in Spain under Protocol ID EMD-07-02. A combined enrollment number is presented. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients were selected from five study sites in the European Union. |
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Condition ICMJE |
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Intervention ICMJE |
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Study Group/Cohort (s) | Travalert with DuoTrav
One drop in study eye(s) once daily in the evening for four months
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 55 | ||||
Completion Date | February 2010 | ||||
Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | France, Italy, Netherlands, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00676637 | ||||
Other Study ID Numbers ICMJE | EMD-07-01, EMD-07-02 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Alcon Research | ||||
Study Sponsor ICMJE | Alcon Research | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Alcon Research | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |