Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01783860
First received: February 1, 2013
Last updated: December 28, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Posterior Blepharitis
Drug: Azithromycin
Drug: Doxycycline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Study of the Effect of Oral Azithromycin on Posterior Blepharitis

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Change of Blepharitis Symptoms Score [ Time Frame: Change from the baseline until 61 days after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Main Ocular Signs [ Time Frame: Change from baseline until 61 days after treatment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change of Total Severity Score Between Baseline and 7 Days Later [ Time Frame: baseline and 7 days later ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Azithromycin (Razak Co., Tehran)
Active Comparator: Doxycycline
Oral doxycycline 100mg capsule every 12 hours for one month
Drug: Doxycycline
Other Name: Doxycycline (Kimidarou Co., Tehran)

  Eligibility

Ages Eligible for Study:   13 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783860

Locations
Iran, Islamic Republic of
Rassoul Akram Hospital
Tehran, Iran, Islamic Republic of, 14455-364
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Mohsen B Kashkouli, MD Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01783860     History of Changes
Other Study ID Numbers: 90-01-124-13076
Study First Received: February 1, 2013
Results First Received: July 16, 2013
Last Updated: December 28, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Azithromycin
Doxycycline
Posterior Blepharitis

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Doxycycline
Doxycycline hyclate
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 22, 2014