Bacterial Infections, Eye Infections
Conditions
Brief summary
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
Interventions
DRUGAzithromycin
azithromycin topical solution 1% given as a single drop in a single eye
DRUGMoxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart
Exclusion criteria
* Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial * Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders) * Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures * Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies * Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Pharmacokinetic Parameters | Up to 24 hours |
Participant flow
Recruitment details
December 2007
Pre-assignment details
Normal volunteers
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose | 6 |
| Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | 6 |
| Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose | 6 |
| Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose | 6 |
| Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose | 6 |
| Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose | 6 |
| Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose | 6 |
| Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose | 6 |
| Total | 48 |
Baseline characteristics
| Characteristic | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 44.5 years STANDARD_DEVIATION 11.1 | 46.8 years STANDARD_DEVIATION 13.1 | 38.2 years STANDARD_DEVIATION 13.2 | 33.7 years STANDARD_DEVIATION 16.8 | 43.0 years STANDARD_DEVIATION 13.7 | 43.5 years STANDARD_DEVIATION 13.2 | 33.3 years STANDARD_DEVIATION 8.2 | 36.7 years STANDARD_DEVIATION 11.7 | 40.0 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 48 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 5 Participants | 2 Participants | 3 Participants | 23 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants | 4 Participants | 3 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 6 | 1 / 6 | 1 / 6 | 0 / 6 | 3 / 6 | 2 / 6 | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Assessment of Pharmacokinetic Parameters
Time frame: Up to 24 hours
Primary
Assessment of Pharmacokinetic Parameters
Conjunctiva Concentration of Azithromycin and Moxifloxacin
Time frame: Over 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose | Assessment of Pharmacokinetic Parameters | 130.8 μg/g | Standard Deviation 89.1 |
| Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 51.6 μg/g | Standard Deviation 26 |
| Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 67.1 μg/g | Standard Deviation 51.8 |
| Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 31.9 μg/g | Standard Deviation 20.4 |
| Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose | Assessment of Pharmacokinetic Parameters | 1.9 μg/g | Standard Deviation 2 |
| Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 3.8 μg/g | Standard Deviation 9 |
| Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 0.0 μg/g | Standard Deviation 0 |
| Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose | Assessment of Pharmacokinetic Parameters | 0.0 μg/g | Standard Deviation 0 |