Bacterial Infections, Eye Infections
Conditions
Brief summary
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
Interventions
DRUGAzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
DRUGVigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2
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 visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study. * Have normal lid anatomy.
Exclusion criteria
* Have an abnormal biomicroscopy or ophthalmoscopy exam. * Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days. * Have used artificial tears in the past thirty days. * Have a diagnosis of on-going ocular infection or lid margin inflammation. * Have ever had penetrating ocular surface or intraocular surgery. * Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite. * Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox. * Have had corneal or lid abnormalities. * Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes. * Have any ocular pathology with the exception of cataracts. * Have a serious systemic disease or uncontrolled medical condition. * Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days. * Have a history of liver or kidney disease resulting in persisting dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AzaSite | 18 |
| Vigamox | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | AzaSite | Vigamox | Total |
|---|---|---|---|
| Age Continuous | 33.9 years STANDARD_DEVIATION 12.59 | 38.1 years STANDARD_DEVIATION 13.29 | 36.0 years STANDARD_DEVIATION 12.92 |
| Sex: Female, Male Female | 13 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
Time frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
Population: Per Protocol Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 15 Minutes | 16.485 µg/mL | Standard Deviation 22.9971 |
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 1 Hour | 4.007 µg/mL | Standard Deviation 4.368 |
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 2 Hours | 1.966 µg/mL | Standard Deviation 3.6632 |
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 8 Hours | 2.590 µg/mL | Standard Deviation 4.8111 |
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 24 Hours | 0.195 µg/mL | Standard Deviation 0.2558 |
| AzaSite | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 4 Hours | 1.558 µg/mL | Standard Deviation 2.6151 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 4 Hours | 0.603 µg/mL | Standard Deviation 1.0074 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 15 Minutes | 8.199 µg/mL | Standard Deviation 15.9873 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 24 Hours | 0.021 µg/mL | Standard Deviation 0.0449 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 1 Hour | 2.221 µg/mL | Standard Deviation 4.1506 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 8 Hours | 1.364 µg/mL | Standard Deviation 2.7629 |
| Vigamox | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 2 Hours | 2.985 µg/mL | Standard Deviation 5.635 |