Bacterial Infections, Cataract Extraction, Eye Infections
Conditions
Brief summary
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
Interventions
DRUGAzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days.
One drop three times a day for seven days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are scheduled to undergo routine cataract surgery by the investigator's preferred technique. * Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.
Exclusion criteria
* Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * Have a history of ocular pemphigoid. * Have ever had penetrating ocular surface surgery. * Have had intraocular surgery within the past 3 months. * Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site. * Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection. * Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery). * Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera. * Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study. * 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. * Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis. * Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin. * Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance. * Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 | Nominal time is scheduled time relative to administration of the first eye drop |
Secondary
| Measure | Time frame |
|---|---|
| Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azasite | 58 |
| Vigamox | 58 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Various | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Azasite | Vigamox | Total |
|---|---|---|---|
| Age Continuous | 71.0 years STANDARD_DEVIATION 7.57 | 66.3 years STANDARD_DEVIATION 10.02 | 68.6 years STANDARD_DEVIATION 9.15 |
| Sex: Female, Male Female | 34 Participants | 28 Participants | 62 Participants |
| Sex: Female, Male Male | 24 Participants | 30 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 58 | 2 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
Primary
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Nominal time is scheduled time relative to administration of the first eye drop
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 1 - 1 hr (AzaSite and Vigamox) | 40.4 ug/g | Standard Deviation 19.7752 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 2 - 12 hrs (AzaSite)/8 hrs (Vigamox) | 33.55 ug/g | Standard Deviation 11.81 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 3 - 48 hrs (AzaSite and Vigamox) | 559.733 ug/g | Standard Deviation 1011.658 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 4 - 49 hrs (AzaSite and Vigamox) | 98.6 ug/g | Standard Deviation 4.535 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox) | 287.75 ug/g | Standard Deviation 433.4355 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 6 - 144 hrs (AzaSite and Vigamox) | 175.017 ug/g | Standard Deviation 88.925 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 7 - 145 hrs (AzaSite and Vigamox) | 269.46 ug/g | Standard Deviation 316.2821 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 8 - 168 hrs (AzaSite and Vigamox) | 261.125 ug/g | Standard Deviation 169.1224 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 9 - 216 hrs (AzaSite and Vigamox) | 273.9 ug/g | Standard Deviation 160.4984 |
| Azasite | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 10 - 312 (AzaSite and Vigamox) | 63.867 ug/g | Standard Deviation 51.1578 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 8 - 168 hrs (AzaSite and Vigamox) | .322 ug/g | Standard Deviation 0.1792 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 1 - 1 hr (AzaSite and Vigamox) | 5.747 ug/g | Standard Deviation 3.4775 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 6 - 144 hrs (AzaSite and Vigamox) | .305 ug/g | Standard Deviation 0.0917 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 2 - 12 hrs (AzaSite)/8 hrs (Vigamox) | 1.051 ug/g | Standard Deviation 0.8099 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 10 - 312 (AzaSite and Vigamox) | .011 ug/g | Standard Deviation 0.0098 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 3 - 48 hrs (AzaSite and Vigamox) | 1.129 ug/g | Standard Deviation 1.1673 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 7 - 145 hrs (AzaSite and Vigamox) | 5.432 ug/g | Standard Deviation 4.0756 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 4 - 49 hrs (AzaSite and Vigamox) | 15.754 ug/g | Standard Deviation 15.4107 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 9 - 216 hrs (AzaSite and Vigamox) | .165 ug/g | Standard Deviation 0.1974 |
| Vigamox | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox) | .862 ug/g | Standard Deviation 0.6801 |
Secondary
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 6 - 144 hrs (AzaSite and Vigamox) | .026 ug/mL | Standard Deviation 0.0175 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 3 - 48 hrs (AzaSite and Vigamox) | .047 ug/mL | Standard Deviation 0.0515 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 7 - 145 hrs (AzaSite and Vigamox) | .052 ug/mL | Standard Deviation 0.0694 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 2- 12 hrs (AzaSite)/ 8 hrs (Vigamox) | .088 ug/mL | Standard Deviation 0.0084 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 8 - 168 hrs (AzaSite and Vigamox) | .035 ug/mL | Standard Deviation 0.0276 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 4 - 49 hrs (AzaSite and Vigamox) | .023 ug/mL | Standard Deviation 0.0183 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 9 - 216 hrs (AzaSite and Vigamox) | .028 ug/mL | Standard Deviation 0.0353 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 5 - 72 hrs (AzaSite)/ 56 hr (Vigamox) | .02 ug/mL | Standard Deviation 0.0099 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 10 - 312 hrs (AzaSite and Vigamox) | .011 ug/mL | Standard Deviation 0.0102 |
| Azasite | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 1- 1 hr (AzaSite and Vigamox) | .022 ug/mL | Standard Deviation 0.0297 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 10 - 312 hrs (AzaSite and Vigamox) | .017 ug/mL | Standard Deviation 0.0189 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 1- 1 hr (AzaSite and Vigamox) | .582 ug/mL | Standard Deviation 0.506 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 2- 12 hrs (AzaSite)/ 8 hrs (Vigamox) | .113 ug/mL | Standard Deviation 0.0729 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 3 - 48 hrs (AzaSite and Vigamox) | .079 ug/mL | Standard Deviation 0.0543 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 5 - 72 hrs (AzaSite)/ 56 hr (Vigamox) | .084 ug/mL | Standard Deviation 0.0261 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 6 - 144 hrs (AzaSite and Vigamox) | .225 ug/mL | Standard Deviation 0.1456 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 7 - 145 hrs (AzaSite and Vigamox) | .669 ug/mL | Standard Deviation 0.402 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 8 - 168 hrs (AzaSite and Vigamox) | .059 ug/mL | Standard Deviation 0.0265 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 9 - 216 hrs (AzaSite and Vigamox) | .071 ug/mL | Standard Deviation 0.0845 |
| Vigamox | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Timepoint 4 - 49 hrs (AzaSite and Vigamox) | .765 ug/mL | Standard Deviation 0.5657 |