Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0034186696
Study information
Scientific title
Glaucoma compliance aids research project
Acronym
Study hypothesis
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Eye Diseases: Glaucoma
Intervention
Glaucoma compliance aids vs no aids.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2006
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary open angle glaucoma patients
2. Patients using prostaglandin analogues anti glaucoma medications only
3. Patients putting eye drops themselves
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients from Ophthalmology outpatients
Participant exclusion criteria
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
Recruitment start date
01/09/2006
Recruitment end date
01/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barnsley Hospital NHS Foundation Trust
Barnsley
S75 2EP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barnsley Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary