Trial Outcomes & Findings for Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis (NCT NCT01478256)

Results Overview

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Four weeks

Results posted on

2013-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Besifloxocin Use of topical besifloxocin twice a day to treat acute blepharitis	Erythromycin Topical Erythromycin ointment twice a day for treatment of acute blepharitis
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Besifloxocin n=15 Participants Use of topical besifloxocin twice a day to treat acute blepharitis	Erythromycin n=15 Participants Topical Erythromycin ointment twice a day for treatment of acute blepharitis	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 10 • n=5 Participants	50 years STANDARD_DEVIATION 12 • n=7 Participants	49 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

Outcome measures

Outcome measures
Measure	Besifloxocin n=15 Participants Use of topical besifloxocin to treat acute blepharitis	Erythromycin n=15 Participants Topical Erythromycin ointment for treatment of acute blepharitis
Improvement in Signs and Symptoms of Blepharitis	15 participants	15 participants

SECONDARY outcome

Timeframe: Three weeks

Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis

Outcome measures

Outcome measures
Measure	Besifloxocin n=15 Participants Use of topical besifloxocin to treat acute blepharitis	Erythromycin n=15 Participants Topical Erythromycin ointment for treatment of acute blepharitis
Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics	15 participants	15 participants

Adverse Events

Besifloxocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Erythromycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George John

George John MD

Phone: 5028949757

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place