Condition category
Eye Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/02/2011
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

Mr Usama Faridi

ORCID ID

Contact details

Ophthalmology Department
Taunton and Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom
+44 (0)1823 342122
usama.faridi@tst.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0249122172

Study information

Scientific title

Acronym

Study hypothesis

What is the relative efficacy and tolerance of three prostaglandin analogue eyedrops?

Ethics approval

Informed consent was obtained from all patients. The study was approved by the local Research Ethics Committee (Somerset Research Ethics Committee) and the Medicines and Healthcare products Regulatory Agency, UK and was run in accordance with the principles of Good Clinical Practice (Helsinki’s declaration).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

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

1. Latanoprost
2. Travoprost
3. Bimatoprost

Intervention type

Drug

Phase

Not Specified

Drug names

prostaglandin: Latanoprost, Travoprost, Bimatoprost

Primary outcome measures

Added March 2008:
A comparison of the efficacy, in terms of intra-ocular pressure reduction.

Secondary outcome measures

Added March 2008:
A comparison of the tolerance profile.

Overall trial start date

01/02/2003

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Added March 2008:
Newly diagnosed patients with ocular hypertension, open angle glaucoma (including primary open angle glaucoma, pseudo-exfoliation and pigment dispersion syndrome) or normal tension glaucoma.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120 patients

Participant exclusion criteria

Added March 2008:
1. Patients <20 years
2. Pregnancy
3. Intraocular pressure (IOP) of 40 mmHg or more
4. Severe visual field loss or scotoma within 5° of fixation
5. Patients with secondary glaucoma
5. History of intraocular surgery in the preceding year
6. Prostaglandin derivative was contraindicated

Recruitment start date

01/02/2003

Recruitment end date

31/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ophthalmology Department
Taunton
TA1 5DA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Taunton and Somerset NHS 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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20456437

Publication citations

  1. Results

    Faridi UA, Saleh TA, Ewings P, Venkateswaran M, Cadman DH, Samarasinghe RA, Vodden J, Claridge KG, Comparative study of three prostaglandin analogues in the treatment of newly diagnosed cases of ocular hypertension, open-angle and normal tension glaucoma., Clin. Experiment. Ophthalmol., 2010, 38, 7, 678-682, doi: 10.1111/j.1442-9071.2010.02305.x.

Additional files

Editorial Notes