Condition category
Eye Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/04/2016
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

Prof I Gottlob

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123109164

Study information

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

Acronym

Study hypothesis

To investigate the effect of this medication which is free from harmful side effects in NAION.

Ethics approval

Not provided at time of registration

Study design

Double-masked randomised and placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Eye Diseases: Non-arteritic anterior ischemic optic neuropathy

Intervention

Randomised controlled trial

Intervention type

Drug

Phase

Not Applicable

Drug names

Brimonidine-Tartrate

Primary outcome measures

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 trial start date

01/07/2001

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with acute non-arteritic anterior ischemic optic neuropathy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/07/2001

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
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

Hospital/treatment centre

Funder name

University Hospitals of Leicester 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

Publication citations

Additional files

Editorial Notes

04/04/2016: No publications found, verifying study status with principal investigator