Comparison of 2 moxifloxacin regimens for preoperative prophylaxis: prospective randomized triple-masked trial. Part 1: aqueous concentration of moxifloxacin.
OBJECTIVE
To evaluate the aqueous concentration of moxifloxacin following 2 dosing regimens of topically administered moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox).


METHODS
Iladevi Cataract & IOL Research Centre, Ahmedabad, India.


METHODS
In this prospective randomized triple-masked clinical trial, 156 patients having cataract surgery were randomly assigned to 1 of 2 regimens of preoperative prophylaxis. In Group A (n = 76), Vigamox was instilled 4 times a day 1 day before surgery plus 1 drop 2 hours before surgery (total of 5 drops). In Group B (n = 76), Vigamox was first instilled 2 hours before surgery and then every 15 minutes for 1 hour (total of 5 drops). In both groups, aqueous samples (0.1 mL) were collected within 2 hours of the first instillation on the day of surgery and stored at -80 degrees C. The antibiotic concentration in all aqueous aspirates was determined using high-performance liquid chromatography. Data were analyzed using the Kolmogorov-Smirnov t test; 95% confidence intervals (CIs) were calculated.


RESULTS
The mean aqueous humor concentration of moxifloxacin was 1.58 microg/mL +/- 0.80 (SD) in Group A and 2.05 +/- 0.72 microg/mL in Group B (P<.0001; 95% CI, -0.72 to -0.22).


CONCLUSIONS
Both dosing regimens produced substantially higher aqueous concentrations than the known minimum inhibitory concentration for Staphylococcus epidermidis. Topical moxifloxacin administered 2 hours before surgery achieved significantly higher aqueous concentrations than topical moxifloxacin administered 1 day before surgery with 1 drop given on the day of surgery.
Vasavada
Abhay R
AR
Iladevi Cataract & IOL Research Centre, Raghudeep Eye Clinic, Memnagar, Ahmedabad, India. icirc@abhayvasavada.com <icirc@abhayvasavada.com>
Gajjar
Devarshi
D
Raj
Shetal M
SM
Vasavada
Vaishali
V
Vasavada
Viraj
V
D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019072:Antibiotic Prophylaxis; D001082:Aqueous Humor / Q000378:metabolism*; D001372:Aza Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D002387:Cataract Extraction; D002851:Chromatography, High Pressure Liquid; D004812:Epidemiologic Methods; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013997:Time Factors
D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D011804:Quinolines; D000077266:Moxifloxacin