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Completed

NCT Number: NCT01783860

Oral Azithromycin Versus Doxycycline in 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.

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Key information

Conditions

Posterior Blepharitis Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

13 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rassoul Akram Hospital

Tehran, Tehran Province, 14455-364, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

Other names: Azithromycin (Razak Co., Tehran)

Doxycycline

Drug

Other names: Doxycycline (Kimidarou Co., Tehran)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Study of the Effect of Oral Azithromycin on Posterior Blepharitis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2013
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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