Adherence Improvement in Glaucoma Patients
This study has been completed.
Sponsor:
Maastricht University Medical Center
Collaborator:
Alcon Laboratories
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00603005
First received: January 15, 2008
Last updated: February 23, 2010
Last verified: February 2010
| Tracking Information | |||||
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| First Received Date ICMJE | January 15, 2008 | ||||
| Last Updated Date | February 23, 2010 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00603005 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Information with regard to the use of eye drops from data generated by the TravAlert dosing system [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adherence Improvement in Glaucoma Patients | ||||
| Official Title ICMJE | Adherence Improvement in Glaucoma Patients | ||||
| Brief Summary | The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Caregiver) Primary Purpose: Supportive Care |
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| Condition ICMJE | Glaucoma | ||||
| Intervention ICMJE | Device: Use of TravAlert dosing aid with or without drop guider
Each patient will use a dosing aid and/or drop guider for 6 months |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* 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 | 802 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00603005 | ||||
| Other Study ID Numbers ICMJE | MEC 07-1-015, CTCM-071015 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. H.J.M. Beckers, MD, phD, Department of Ophthalmology, University Hospital Maastricht | ||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||
| Collaborators ICMJE | Alcon Laboratories | ||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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