Posterior Blepharitis
Conditions
Keywords
Azithromycin, Doxycycline, Posterior Blepharitis
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.
Interventions
DRUGAzithromycin
DRUGDoxycycline
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
13 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Blepharitis Symptoms Score | 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. |
| Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Main Ocular Signs | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of Total Severity Score Between Baseline and 7 Days Later | 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. |
| Change of Total Severity Score Between Baseline and 31 Days Later | 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. |
| Change of Total Severity Score Between Baseline and 37 Days Later | 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. |
Countries
Iran
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline Oral doxycycline 100mg capsule every 12 hours for one month
Doxycycline : | 50 |
| Oral Azithromycin Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Azithromycin : | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Doxycycline | Oral Azithromycin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 43 Participants | 89 Participants |
| Region of Enrollment Iran, Islamic Republic of | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 12 / 50 | 3 / 50 |
Outcome results
Primary
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.
Time frame: Change from the baseline until 61 days after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Change of Blepharitis Symptoms Score | 1.8 score | Standard Deviation 2.5 |
| Oral Azithromycin | Change of Blepharitis Symptoms Score | 2.8 score | Standard Deviation 2.2 |
p-value: 0.03t-test, 1 sided
Primary
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.
Time frame: zero time and 61 days later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score | 6.5 units on a scale | Standard Deviation 4.1 |
| Oral Azithromycin | Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score | 8.6 units on a scale | Standard Deviation 3.6 |
p-value: 0.007t-test, 1 sided
Secondary
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.
Time frame: Change from baseline until 61 days after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Main Ocular Signs | 4.7 units on a scale | Standard Deviation 2.3 |
| Oral Azithromycin | Main Ocular Signs | 5.7 units on a scale | Standard Deviation 2 |
p-value: 0.01t-test, 1 sided
Other Pre-specified
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.
Time frame: baseline and 31 days later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Change of Total Severity Score Between Baseline and 31 Days Later | 5.2 units on a scale | Standard Deviation 2.4 |
| Oral Azithromycin | Change of Total Severity Score Between Baseline and 31 Days Later | 6.4 units on a scale | Standard Deviation 2.6 |
p-value: 0.02t-test, 1 sided
Other Pre-specified
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.
Time frame: baseline and 37 days later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Change of Total Severity Score Between Baseline and 37 Days Later | 6.3 units on a scale | Standard Deviation 3.2 |
| Oral Azithromycin | Change of Total Severity Score Between Baseline and 37 Days Later | 7.4 units on a scale | Standard Deviation 3 |
p-value: 0.08t-test, 1 sided
Other Pre-specified
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.
Time frame: baseline and 7 days later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doxycycline | Change of Total Severity Score Between Baseline and 7 Days Later | 3.9 units on a scale | Standard Deviation 2.5 |
| Oral Azithromycin | Change of Total Severity Score Between Baseline and 7 Days Later | 4.3 units on a scale | Standard Deviation 2.6 |
p-value: >0.05t-test, 1 sided