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 |
| Protocol serial number | N0123109164 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-masked randomised and placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Brimonidine-Tartrate |
| Primary outcome measure(s) |
Safety of 0.2% Brimonidine-Tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/04/2016: No publications found, verifying study status with principal investigator
