A comparative study of the efficacy and tolerance of three antiglaucoma prostaglandin analogue eyedrops (Latanoprost, Travoprost and Bimatoprost)
| ISRCTN | ISRCTN91423473 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91423473 |
| Secondary identifying numbers | N0249122172 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Usama Faridi
Scientific
Scientific
Ophthalmology Department
Taunton and Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom
| Phone | +44 (0)1823 342122 |
|---|---|
| usama.faridi@tst.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | What is the relative efficacy and tolerance of three prostaglandin analogue eyedrops? |
| Ethics approval(s) | 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 (Helsinkis declaration). |
| Health condition(s) or problem(s) studied | Eye Diseases: Glaucoma |
| Intervention | 1. Latanoprost 2. Travoprost 3. Bimatoprost |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | prostaglandin: Latanoprost, Travoprost, Bimatoprost |
| Primary outcome measure | 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 study start date | 01/02/2003 |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 120 patients |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ophthalmology Department
Taunton
TA1 5DA
United Kingdom
TA1 5DA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Taunton and Somerset NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |
