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Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

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ClinicalTrials.gov Identifier: NCT01783860
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

February 1, 2013
February 5, 2013
July 16, 2013
February 12, 2014
February 12, 2014
January 2013
July 2013   (Final data collection date for primary outcome measure)
  • Change of Blepharitis Symptoms Score [ Time Frame: Change from the baseline until 61 days after treatment ]
    Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.
  • Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score [ Time Frame: zero time and 61 days later ]
    Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.
Improvement of blepharitis [ Time Frame: Change from the baseline until 61 days after treatment ]
Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment
Complete list of historical versions of study NCT01783860 on ClinicalTrials.gov Archive Site
Main Ocular Signs [ Time Frame: Change from baseline until 61 days after treatment ]
lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.
Main Ocular Signs [ Time Frame: Change from baseline until 61 days after treatment ]
lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment
  • Change of Total Severity Score Between Baseline and 7 Days Later [ Time Frame: baseline and 7 days later ]
    Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.
  • Change of Total Severity Score Between Baseline and 31 Days Later [ Time Frame: baseline and 31 days later ]
    Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.
  • Change of Total Severity Score Between Baseline and 37 Days Later [ Time Frame: baseline and 37 days later ]
    Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.
The total clinical severity score [ Time Frame: Change from baseline until 61 days after treatment ]
The total clinical severity score was calculated simply by adding total clinical symptoms and total clinical sings scores (range 0-36) in each visit. Furthermore, the patients' therapeutic at Baseline, and days 7, 31, 37 and 61 after treatment responses were classified according to the reduction of global severity score (symptoms score and signs score) as: excellent (76-100% reduction), good (51-75% reduction), fair (26-50% reduction), and poor (1-25% reduction) or even worse (less than 0%).
 
Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
Study of the Effect of Oral Azithromycin on Posterior Blepharitis

One hundred patients with the diagnosis of posterior blepharitis based on history taking and proper physical examinations by two experienced ophthalmologists will include in the study.

Patients will diagnose with posterior blepharitis if they score at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria. Patients will exclude if they have the following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines.

Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours for one month) in a double-blinded fashion. each patients in both treatment groups will accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes each in the treatment period. Symptoms and signs were recorded for each patient in two treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61 after treatment.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Posterior Blepharitis
  • Drug: Azithromycin
    Other Name: Azithromycin (Razak Co., Tehran)
  • Drug: Doxycycline
    Other Name: Doxycycline (Kimidarou Co., Tehran)
  • Experimental: Oral Azithromycin
    Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
    Intervention: Drug: Azithromycin
  • Active Comparator: Doxycycline
    Oral doxycycline 100mg capsule every 12 hours for one month
    Intervention: Drug: Doxycycline
Kashkouli MB, Fazel AJ, Kiavash V, Nojomi M, Ghiasian L. Oral azithromycin versus doxycycline in meibomian gland dysfunction: a randomised double-masked open-label clinical trial. Br J Ophthalmol. 2015 Feb;99(2):199-204. doi: 10.1136/bjophthalmol-2014-305410. Epub 2014 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients were diagnosed with posterior blepharitis if they scored at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria

Exclusion Criteria:

Patients were excluded if they had the following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines

Sexes Eligible for Study: All
13 Years to 90 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01783860
90-01-124-13076
Yes
Not Provided
Not Provided
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Study Director: Mohsen B Kashkouli, MD Tehran University of Medical Sciences
Tehran University of Medical Sciences
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP