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ISRCTN
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ISRCTN25754048
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ClinicalTrials.gov identifier
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Public title
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Glaucoma compliance aids research project
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0034186696
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Study hypothesis
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1. Do patients receiving glaucoma compliance aids show higher compliance rates with their mediations than those without the aids?
2. Do patients rate the treatment aid as easy to use?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Eye Diseases: Glaucoma
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Participants - inclusion criteria
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1. Primary open angle glaucoma patients
2. Patients using prostaglandin analogues anti glaucoma medications only
3. Patients putting eye drops themselves
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Participants - exclusion criteria
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1. Patients with other eye problems
2. Patients using more than one topical medication
3. Patients not able to consent to participate in the project
4. Patients not putting eye drops themselves
5. Patients under the age of 40 years of age
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Anticipated start date
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01/09/2006
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Anticipated end date
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01/03/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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100 patients from Opthamology outpatients
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Interventions
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Glaucoma compliance aids vs no aids.
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Primary outcome measure(s)
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1. Improvement of compliance in using glaucoma medications, based on rates of using the daily treatment dose before and after using the glaucoma compliance aid.
2. Ease of using compliance aids, based on patients answers to questions related to: squeezing out drops, getting drops into eye, difficulty in squeezing bottle, difficulty in controlling number of drops, difficulty aiming drops.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Barnsley Hospital NHS Foundation Trust
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Trial website
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Publications
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Contact name
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Mrs
Carol
Lomas
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Address
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City/town
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Barnsley
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Zip/Postcode
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S75 2EP
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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24/10/2007
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Date ISRCTN assigned
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28/09/2007
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