Efficacy, tolerability and safety of 0.2% Brimonidine-Tartrate for the treatment of acute non-arteritic anterior ischaemic optic neuropathy
| ISRCTN | ISRCTN72549635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72549635 |
| Secondary identifying numbers | N0123109164 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof I Gottlob
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Study design | Double-masked randomised and placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy, tolerability and safety of 0.2% Brimonidine-Tartrate for the treatment of acute non-arteritic anterior ischaemic optic neuropathy (NAION): a 3-month, double-masked, randomised and placebo-controlled trial |
| Study objectives | To investigate the effect of this medication which is free from harmful side effects in NAION. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Non-arteritic anterior ischemic optic neuropathy |
| Intervention | Randomised controlled trial |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Brimonidine-Tartrate |
| Primary outcome measure | Safety of 0.2% Brimonidine-Tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2001 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with acute non-arteritic anterior ischemic optic neuropathy |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
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
Hospital/treatment centre
University Hospitals of Leicester 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 |
Editorial Notes
04/04/2016: No publications found, verifying study status with principal investigator
