Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547147995
Study information
Scientific title
Acronym
Study hypothesis
Travoprost is a new prostaglandin analogue recently approved for treatment of ocular hypertension and glaucoma.
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
Not specified
Trial type
Treatment
Patient information sheet
Condition
Eye Diseases: Glaucoma
Intervention
Prospective randomised controlled observer blinded clinical trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary clinical outcome measure is diurnal IOP at follow up phasing: the major comparison is to be made between the IOP for travoprost treatment group and for the non-treatment group.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2004
Overall trial end date
01/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Adults with normal tension glaucoma.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
25-30 patients
Participant exclusion criteria
1. Patients on systemic medication
2. Patients who have undergone intraocular eye surgery
Recruitment start date
01/04/2004
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Senior House Officer
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18511540
Publication citations
-
Results
Ang GS, Kersey JP, Shepstone L, Broadway DC, The effect of travoprost on daytime intraocular pressure in normal tension glaucoma: a randomised controlled trial., Br J Ophthalmol, 2008, 92, 8, 1129-1133, doi: 10.1136/bjo.2007.135269.