Condition category
Eye Diseases
Date applied
15/12/2008
Date assigned
23/12/2008
Last edited
02/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Enrique Villegas Becerril

ORCID ID

Contact details

Hospital Publico de Hospitales del Alto Guadalquivir
C/ Miguel Quintero Merino s/n
Polígono Industrial Las Acacias
Puente Genil
Córdoba
CP 14500
Spain
+34 (0) 957 61 50 00
evillegas@ephag.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Doxycycline and dexamethasone as effective topical treatments for blepharitis: a phase IV open randomised controlled therapeutic equivalence trial

Acronym

Study hypothesis

Comparison between oral doxycycline and topical dexamethasone versus topical doxycycline and dexamethasone for the treatment of blepharitis.

On 19/03/2009 the following changes were made to the trial record:
1. The target number of participants was changed from 100 to 10 to 25 participants.
2. The sources of funding field was updated from 'Brudy Technology (Spain) - covering treatment costs' to 'Investigator-funded (Spain)'.

Ethics approval

Not provided at time of registration

Study design

Phase IV open randomised controlled therapeutic equivalence trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Blepharitis

Intervention

Current interventions as of 19/03/2009:
Group 1: topical doxycycline 0.05% and topical dexamethasone 0.05% (the two drugs mixed into a single ointment) to be applied four times a day for four days, three times a day for four days, twice a day for four days and finally once a day for four days
Group 2: oral doxycycline 100 mg twice a day for 16 days, and topical dexamethasone 0.05% to be applied four times a day for four days, three times a day for four days, twice a day for four days and once a day for four days

Previous interventions:
Group 1: topical doxycycline 0.05% and topical dexamethasone 0.05% (the two drugs mixed into a single ointment) to be applied three times a day during week 1, twice a day during week 2, and once a day during week 3
Group 2: oral doxycycline 100 mg twice/day for 14 days, then 100 mg once a day for 7 days and topical dexamethasone 0.05% to be applied three times a day during week 1, twice a day during week 2, and once a day during week 3.

Updated 30/04/2014: the trial was stopped due to lack of funding.

Intervention type

Drug

Phase

Phase IV

Drug names

Doxycycline, dexamethasone

Primary outcome measures

Symptoms assessed with a questionnaire (with a numerical scale): improvement of comfort, assessed before first treatment (baseline) and between 1 and 7 days after the end of treatment.

Secondary outcome measures

1. Presence or absence of conjunctival infection before and after treatment
2. Safety of topical doxycycline compared with oral doxycycline

Duration of follow-up: 16 days (updated 19/03/2009; previously 20 days)

Overall trial start date

01/02/2009

Overall trial end date

01/05/2009

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Both males and females, aged older than 18 years
2. No other topical treatments
3. Diagnosis of blepharitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 to 25 participants

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/02/2009

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Publico de Hospitales del Alto Guadalquivir
Córdoba
CP 14500
Spain

Sponsor information

Organisation

Puente Genil Hospital (Hospital de Alta Resolución de Puente Genil) (Spain)

Sponsor details

C/ Miguel Quintero Merino s/n
Polígono Industrial Las Acacias
14500 Puente Genil
Córdoba
14011
Spain
+34 (0) 957 61 50 00
evillegas@ephag.es

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator-funded (Spain)

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