Trial Outcomes & Findings for Oral Azithromycin Versus Doxycycline in Posterior Blepharitis (NCT NCT01783860)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Change from the baseline until 61 days after treatment

Results posted on

2014-02-12

Participant Flow

All 100 patients were selected from the eye clinic of Rasoule-Akram hospital during the study period. The patients were recruited sequentially.

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.

Participant milestones

Participant milestones
Measure	Doxycycline Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Change of Blepharitis Symptoms Score	1.8 score Standard Deviation 2.5	2.8 score Standard Deviation 2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
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	8.6 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Main Ocular Signs	4.7 units on a scale Standard Deviation 2.3	5.7 units on a scale Standard Deviation 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Change of Total Severity Score Between Baseline and 7 Days Later	3.9 units on a scale Standard Deviation 2.5	4.3 units on a scale Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Change of Total Severity Score Between Baseline and 31 Days Later	5.2 units on a scale Standard Deviation 2.4	6.4 units on a scale Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Doxycycline n=50 Participants Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 Participants Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Change of Total Severity Score Between Baseline and 37 Days Later	6.3 units on a scale Standard Deviation 3.2	7.4 units on a scale Standard Deviation 3

Adverse Events

Doxycycline

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Azithromycin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Doxycycline n=50 participants at risk Oral doxycycline 100mg capsule every 12 hours for one month Doxycycline :	Oral Azithromycin n=50 participants at risk Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. Azithromycin :
Gastrointestinal disorders vomiting and loss of appetide	24.0% 12/50	6.0% 3/50

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohsen Bahmani-Kashkouli

Rasoule-Akram Hospital

Phone: 00982166558811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place