OBJECTIVE: To investigate the effects of moxifloxacin on the cornea of normal human eyes using confocal microscopy and slit-lamp biomicroscopy. METHODS: This study enrolled adult volunteers who had a normal baseline ophthalmic examination. The dose regimen, similar to that of patients undergoing cataract extraction, was one drop of moxifloxacin in one eye four times a day for 3 days. The untreated fellow eye served as the control. Subjects had a baseline examination (Visit 1), started moxifloxacin the next day, and were examined 24 h (Visit 2) and 72 h (Visit 3) after starting medication. At each visit, visual acuity and adverse effects were recorded, slit-lamp examination with fluorescein was used to measure tear break-up time, and endothelial and epithelial cell counts were determined using confocal microscopy. RESULTS: Fifteen volunteers (mean age 37 +/- 7 years) enrolled. No significant difference in visual acuity, tear break-up time, endothelial or epithelial cell counts was noted between the treated and fellow eye. Subjects experienced no significant decrease in visual acuity, tear break-up time, or endothelial cell counts during the 3-day treatment period in either eye. Epithelial cell counts were stable at Visits 1 and 2, and decreased similarly in the treated and control eye at Visit 3. CONCLUSIONS: Moxifloxacin was safe for use during the 3-day treatment period. Moxifloxacin causes no significant epithelial or endothelial toxicity, and has no effect on visual acuity or ocular surface integrity in healthy subjects treated using a dosing regimen that simulated prophylactic use following cataract surgery.
OBJECTIVE: To investigate the effects of moxifloxacin on the cornea of normal human eyes using confocal microscopy and slit-lamp biomicroscopy. METHODS: This study enrolled adult volunteers who had a normal baseline ophthalmic examination. The dose regimen, similar to that of patients undergoing cataract extraction, was one drop of moxifloxacin in one eye four times a day for 3 days. The untreated fellow eye served as the control. Subjects had a baseline examination (Visit 1), started moxifloxacin the next day, and were examined 24 h (Visit 2) and 72 h (Visit 3) after starting medication. At each visit, visual acuity and adverse effects were recorded, slit-lamp examination with fluorescein was used to measure tear break-up time, and endothelial and epithelial cell counts were determined using confocal microscopy. RESULTS: Fifteen volunteers (mean age 37 +/- 7 years) enrolled. No significant difference in visual acuity, tear break-up time, endothelial or epithelial cell counts was noted between the treated and fellow eye. Subjects experienced no significant decrease in visual acuity, tear break-up time, or endothelial cell counts during the 3-day treatment period in either eye. Epithelial cell counts were stable at Visits 1 and 2, and decreased similarly in the treated and control eye at Visit 3. CONCLUSIONS:Moxifloxacin was safe for use during the 3-day treatment period. Moxifloxacin causes no significant epithelial or endothelial toxicity, and has no effect on visual acuity or ocular surface integrity in healthy subjects treated using a dosing regimen that simulated prophylactic use following cataract surgery.