Trial Outcomes & Findings for Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers (NCT NCT00564447)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

Up to 24 hours

Results posted on

2011-09-22

Participant Flow

December 2007

Normal volunteers

Participant milestones

Participant milestones
Measure	Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose	Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose	Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose	Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose
Overall Study STARTED	6	6	6	6	6	6	6	6
Overall Study COMPLETED	6	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose n=6 Participants	Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose n=6 Participants	Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose n=6 Participants	Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose n=6 Participants	Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose n=6 Participants	Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose n=6 Participants	Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose n=6 Participants	Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose n=6 Participants	Total n=48 Participants Total of all reporting groups
Age Continuous	44.5 years STANDARD_DEVIATION 11.1 • n=5 Participants	46.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	38.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	33.7 years STANDARD_DEVIATION 16.8 • n=4 Participants	43.0 years STANDARD_DEVIATION 13.7 • n=21 Participants	43.5 years STANDARD_DEVIATION 13.2 • n=8 Participants	33.3 years STANDARD_DEVIATION 8.2 • n=8 Participants	36.7 years STANDARD_DEVIATION 11.7 • n=24 Participants	40.0 years STANDARD_DEVIATION 12.8 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	23 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	25 Participants n=42 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	6 participants n=8 Participants	6 participants n=24 Participants	48 participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 24 hours

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Over 24 hours

Conjunctiva Concentration of Azithromycin and Moxifloxacin