Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

NCT01783860 | Completed Phase 2 Results DMC

• 1 other identifier: 90-01-124-13076
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posterior Blepharitis

Keywords

Azithromycin; Doxycycline; Posterior Blepharitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Main Ocular Signs

  Change from baseline until 61 days after treatment

Other Outcomes (3)

• Change of Total Severity Score Between Baseline and 7 Days Later

  baseline and 7 days later

• Change of Total Severity Score Between Baseline and 31 Days Later

  baseline and 31 days later

• Change of Total Severity Score Between Baseline and 37 Days Later

  baseline and 37 days later

Study Arms (2)

Oral Azithromycin

EXPERIMENTAL

Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.

Drug: Azithromycin

Doxycycline

ACTIVE COMPARATOR

Oral doxycycline 100mg capsule every 12 hours for one month

Drug: Doxycycline

Interventions

Azithromycin DRUG

Also known as: Azithromycin (Razak Co., Tehran)

Oral Azithromycin

Doxycycline DRUG

Also known as: Doxycycline (Kimidarou Co., Tehran)

Doxycycline

Eligibility Criteria

• Age: 13 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Rassoul Akram Hospital

Tehran, Tehran Province, 14455-364, Iran

Location

Related Publications (1)

• 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.

  PMID: 25138765 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Mohsen Bahmani-Kashkouli
• Organization: Rasoule-Akram Hospital

bahmanik@eyeplasticsurgeries.com

00982166558811

Study Officials

• Mohsen B Kashkouli, MD

  Tehran University of Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2013-12

Locations

IR (1)