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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Posterior Blepharitis
Interventions Drug: Azithromycin
Drug: Doxycycline
Enrollment 100
Recruitment Details All 100 patients were selected from the eye clinic of Rasoule-Akram hospital during the study period. The patients were recruited sequentially.
Pre-assignment Details Patients were excluded if they had: age< 12 years,history of ocular or lacrimal surgery,previous usage of contact lenses,history of ocular allergy or systemic diseases with ocular involvement, history of usage of topical or systemic antibiotic in the last month, pregnant or lactating mothers, liver failure and history of sensitivity to Cyclines.
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Doxycycline Oral Azithromycin Total
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Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
2
   4.0%
4
   8.0%
6
   6.0%
Between 18 and 65 years
46
  92.0%
43
  86.0%
89
  89.0%
>=65 years
2
   4.0%
3
   6.0%
5
   5.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
24
  48.0%
26
  52.0%
50
  50.0%
Male
26
  52.0%
24
  48.0%
50
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Change of Blepharitis Symptoms Score
Hide Description 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.
Time Frame Change from the baseline until 61 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score
1.8  (2.5) 2.8  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score
Hide Description 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.
Time Frame zero time and 61 days later
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (4.1) 8.6  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Main Ocular Signs
Hide Description 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.
Time Frame Change from baseline until 61 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (2.3) 5.7  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change of Total Severity Score Between Baseline and 7 Days Later
Hide Description 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.
Time Frame baseline and 7 days later
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (2.5) 4.3  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change of Total Severity Score Between Baseline and 31 Days Later
Hide Description 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.
Time Frame baseline and 31 days later
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (2.4) 6.4  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change of Total Severity Score Between Baseline and 37 Days Later
Hide Description 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.
Time Frame baseline and 37 days later
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description:

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (3.2) 7.4  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline, Oral Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline Oral Azithromycin
Hide Arm/Group Description

Oral doxycycline 100mg capsule every 12 hours for one month

Doxycycline :

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

Azithromycin :

All-Cause Mortality
Doxycycline Oral Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline Oral Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   12/50 (24.00%)   3/50 (6.00%) 
Gastrointestinal disorders     
vomiting and loss of appetide *  12/50 (24.00%)  3/50 (6.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxycycline Oral Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mohsen Bahmani-Kashkouli
Organization: Rasoule-Akram Hospital
Phone: 00982166558811
EMail: bahmanik@eyeplasticsurgeries.com
Layout table for additonal information
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01783860     History of Changes
Other Study ID Numbers: 90-01-124-13076
First Submitted: February 1, 2013
First Posted: February 5, 2013
Results First Submitted: July 16, 2013
Results First Posted: February 12, 2014
Last Update Posted: February 12, 2014