Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2008
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

Dr H G Lemij

ORCID ID

Contact details

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 7777
Lemij@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OZR-2000-07; NTR139

Study information

Scientific title

Acronym

AION

Study hypothesis

Administration of brimonidine eye drops in patients with acute ischaemic optic neuropathy (AION) reduces loss of vision.

Ethics approval

Received from local medical ethics committee

Study design

Randomised, double-blind, placebo controlled, parallel group, two-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute ischaemic optic neuropathy

Intervention

Topical treatment with brimonidine (0.5%) eye drops.

Intervention type

Drug

Phase

Not Specified

Drug names

Brimonidine

Primary outcome measures

Thickness of peripapillary nerve fiber layer.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2001

Overall trial end date

01/08/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Arteric or non-arteric AION

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Onset of symptoms greater than 5 days ago at presentation
2. Inability to undergo GDx or HFA measurement

Recruitment start date

01/02/2001

Recruitment end date

01/08/2002

Locations

Countries of recruitment

Netherlands

Trial participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Organisation

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)

Sponsor details

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 77 77
info@oogziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)

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