Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Carol Lomas

ORCID ID

Contact details

Barnsley Hospital NHS Foundation Trust
Barnsley
S75 2EP
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes