Doxycycline and dexamethasone as effective topical treatments for blepharitis

ISRCTN	ISRCTN99872501
DOI	https://doi.org/10.1186/ISRCTN99872501
Secondary identifying numbers	N/A

Submission date: 15/12/2008
Registration date: 23/12/2008
Last edited: 02/10/2014

Recruitment status: Stopped
Overall study status: Stopped
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

Dr Enrique Villegas Becerril
Scientific

Hospital Publico de Hospitales del Alto Guadalquivir
C/ Miguel Quintero Merino s/n
Polígono Industrial Las Acacias
Puente Genil
Córdoba
CP 14500
Spain

Phone	+34 (0) 957 61 50 00
Email	evillegas@ephag.es

Study information

Study design	Phase IV open randomised controlled therapeutic equivalence trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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	Doxycycline and dexamethasone as effective topical treatments for blepharitis: a phase IV open randomised controlled therapeutic equivalence trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Doxycycline, dexamethasone
Primary outcome measure	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 study start date	01/02/2009
Completion date	01/05/2009
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	10 to 25 participants
Key inclusion criteria	1. Both males and females, aged older than 18 years 2. No other topical treatments 3. Diagnosis of blepharitis
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/02/2009
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Publico de Hospitales del Alto Guadalquivir

Córdoba
CP 14500
Spain

Sponsor information

Puente Genil Hospital (Hospital de Alta Resolución de Puente Genil) (Spain)
Hospital/treatment centre

C/ Miguel Quintero Merino s/n
Polígono Industrial Las Acacias
14500 Puente Genil
Córdoba
14011
Spain

Phone	+34 (0) 957 61 50 00
Email	evillegas@ephag.es

Funders

Funder type

Other

Investigator-funded (Spain)

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