Comparison between the therapeutic effect of massage and drops of 1% azithromycin with massage and doxycycline 100 mg capsules on the treatment of posterior blepharitis
Objective: the comparison between the therapeutic effect of massage and drops of 1% azithromycin with massage and doxycycline 100 mg capsules on treatment of posterior blepharitis.
Design: Randomized controlled trial (block method)
Inclusion criteria: patients with posterior blepharitis aged 20 to 50 years, moderate blepharitis Grade 3.
Exclusion criteria: blepharitis previously treated, severe blepharitis, concurrent ocular disorders.
Sample size: Fifty patients with posterior blepharitis based on inclusion and exclusion criteria are chosen randomly divided into two groups.
Groups, interventions and times of interventions: Group A: The group receiving ocular massage and drops azithromycin 1 %( 14- days ocular massage +2 drops, twice a day for 2 days and then 2 drops, once a day, for 12 days). Group B: The group receiving ocular massage and oral doxycycline 100 mg capsules (14-days ocular massage+1 Doxycycline capsule once day for 4 weeks). Posterior blepharitis symptoms for both groups before the intervention, one week after the intervention and at the end of the treatment are recorded. (Via Schirmer test, ocular symptoms and physical examination). The efficacy of the two methods in the treatment of posterior blepharitis signs and symptoms are compared with each other.
Primary outcomes: Schirmer test, the patient's ocular symptoms and the patient's clinical examinations are done and registered in 3 times (before intervention (first visit), 1 week after intervention and at the end of the treatment period).
Secondary outcomes: drug side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120515119N2
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Mehdi Zandian
Name of organization / entity
Hamadan University of Health and Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0572
Email address
m.zandian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the therapeutic effect of massage and drops of 1% azithromycin with massage and doxycycline 100 mg capsules on the treatment of posterior blepharitis
Public title
Comparison of Therapeutic effect of azithromycin drops and doxycycline capsules on treatment of eyelid inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with posterior blepharitis (b) aged 20 to 50 years, (c) moderate blepharitis Grade 3
Exclusion criteria: (a) blepharitis previously treated, (b) severe blepharitis, (c) concurrent ocular disorders.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method : Randomization was performed by block randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmide Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-01-02, 1390/10/12
Ethics committee reference number
د/پ/16/35/9/3494
Health conditions studied
1
Description of health condition studied
Posterior Blepharitis
ICD-10 code
H01.0
ICD-10 code description
Blepharitis
Primary outcomes
1
Description
Eye dryness
Timepoint
The first visit, 1 week later and at the end of the treatment period
Method of measurement
Shirmer Test
2
Description
Eye Pruritus
Timepoint
The first visit, 1 week later and at the end of the treatment period
Method of measurement
Questionnaire
3
Description
Corneal or conjunctiva staining
Timepoint
The first visit, 1 week later and at the end of the treatment period
Method of measurement
Slit Lamp
Secondary outcomes
1
Description
Any side effect such as allergy
Timepoint
The first visit, 1 week later and at the end of the treatment period
Method of measurement
Questionnaire
Intervention groups
1
Description
Azithromycin 1% drop, produced by Sina Darou Company, 2 drops 2 times a day for 2 days than 1 drop daily for 12 days
Category
Treatment - Drugs
2
Description
Doxycycline 100 mg Capsule, produced by Razak company, Once a day for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mehdi Zandian
Street address
Farshchian Hospital, Mirzade Eshghi Ave.
City
Hamadan
2
Recruitment center
Name of recruitment center
Sheikharaes Clinic
Full name of responsible person
Mehdi Zandian
Street address
Khajerashid Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mehdi Zandian
Position
MD, PhD of Ophthalmology / Assistant professor of Ophthalmology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Ave.
City
Hamadan
Postal code
Phone
+98 81 1838 0090
Fax
Email
m.zandian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mehdi Zandian
Position
MD, PhD of Ophthalmology / Assistant Professor of Ophthalmology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Ave.
City
Hamadan
Postal code
Phone
+98 81 1828 5011
Fax
Email
m.zandian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Neda Rahimian
Position
Intern / Medical student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Ave.
City
Hamadan
Postal code
Phone
Fax
Email
nikan1989@yahoo.co.in
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)