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.

Study Overview

• Status: Completed
• Conditions: Posterior Blepharitis
• Intervention / Treatment: Drug: Azithromycin; Drug: Doxycycline

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 14455-364
    • Rassoul Akram Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Azithromycin; Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.	Drug: Azithromycin; Other Names: Azithromycin (Razak Co., Tehran)
Active Comparator: Doxycycline; Oral doxycycline 100mg capsule every 12 hours for one month	Drug: Doxycycline; Other Names: Doxycycline (Kimidarou Co., Tehran)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Blepharitis Symptoms Score	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 from the baseline until 61 days after treatment
Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score	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.	zero time and 61 days later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Ocular Signs	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.	Change from baseline until 61 days after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Total Severity Score Between 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.	baseline and 7 days later
Change of Total Severity Score Between 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.	baseline and 31 days later
Change of Total Severity Score Between 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.	baseline and 37 days later

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Mohsen B Kashkouli, MD, Tehran University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: December 28, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Azithromycin; Doxycycline; Posterior Blepharitis
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Blepharitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Azithromycin
• Other Study ID Numbers: 90-01-124-13076